Heart Pro III 3.8

Hearts Rules

  1. Take Me To The Top (Correct Version) guitar tab by Motley Crue with free online tab player. One accurate version. Recommended by The Wall Street Journal.
  2. Proverbs 3:5-8 NIV. Trust in the LORD with all your heart and lean not on your own understanding; in all your ways submit to him, and he will make your paths straight. Do not be wise in your own eyes; fear the LORD and shun evil. This will bring health to your body and nourishment to your bones.

(185) Draft Guidance for Industry and FDA Staff: Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications ODE/DCD/CSPB 1607: (186) Guidance for Annuloplasty Rings 510(k) Submissions; Final Guidance for Industry and FDA Staff ODE/DCD/CSPB.

These are the rules I use for Hearts. There are many variations possible, but I use the basic ones from Wikipedia.

  1. The objective of Hearts is to get as few points as possible. Each heart gives one penalty point. There is also one special card, the Queen of spades, which gives 13 penalty points.
  2. When the game starts you select 3 cards to pass to one of your opponents. Typically you want to pass your three worst cards to get rid of them. Which opponent you pass to varies, you start by passing to the opponent on your left, then in the next game you pass to the opponent on your right, third game you pass across the table and in the fourth game there is no card passing.
  3. Each turn starts with one player playing a single card, also called leading. The suit of that card determines the suit of the trick. The other players then play one card each. If they have a card in the same suit as the first card then they must play that. If they don't then they can play one of their other cards. Once four cards have been played, the player who played the highest ranking card in the original suit takes the trick, i.e. he takes the four cards on the table and he then starts the next turn. Any penalty cards in the trick (hearts or queen of spades) are added to the players penalty score. So you want to avoid taking any tricks that have hearts or the queen of spades.
  4. The player who has the two of clubs at the start of the game leads in the first hand, and he MUST lead with the two of clubs.
  5. You cannot lead a trick with hearts, until hearts has been broken (played on another suit). So if it is your turn to lead and no heart has been played yet then you may not select a heart as the card to play first. In some variations of the game you can't play the queen of spades until hearts has been broken as well, but in this version you can always play the queen of spades and she doesn't break hearts.
  6. In the very first round you may never play a heart or the queen of spades, not even if you don't have any card in the suit of the lead card.
  7. Once all cards have been played the penalty points are counted and the player with the fewest points wins that hand. When one or more players reach 100 points or more then the entire game is finished, and the player with the least points win. If points are over 100 and there are two or more equal with the least points then play continues until there's only one winner.
  8. Shooting the Moon! Generally it's bad to get penalty cards, but there is one extra twist! If you get ALL the penalty cards (13 hearts + Queen of spades) then you get 0 points and the other 3 players get 26 points each! This is called Shooting the Moon. Trying this can be a really risky move though, since if another player gets just one of the hearts you'll end up with a lot of points...

As of 21.02.2014 I've changed the game so the Queen of Spades no longer breaks hearts. I used to get complaints that it didn't, then when I changed it to make sure she did break then I got even more complaints about that. So, it looks like most people want the Queen of Spades to not break hearts, so that's the way it'll be from now on. Please do not write to me requesting that I change this again!

About Hearts

This online version of the classic card game Hearts was made by me. My name is Einar Egilsson and over there on the left is my current Facebook profile picture! Hearts is the third card game I've made, the other two are Shithead and Crazy Eights. I used to play Hearts a lot when I was younger, it was one of the games that came with every version of Windows. I wanted to be able to play Hearts online, and just didn't think all the hundreds of other versions of Hearts would do! Of the card games I've made, Hearts is probably my favorite. At least I play it a lot more than the others.

The game is made using html+JavaScript+css with jQuery used for the animations. All the graphics used for the game I found at OpenClipArt, a great site with free graphics. The excellent playing card images were made by Nicu Buculei, and the player images were made by Gerald G.

Any comments, questions, ideas for other games or anything else can be sent to admin@cardgames.io.

This is version 2461 of Hearts.

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Generic Name: Dicyclomine hydrochloride
Dosage Form: oral solution

Medically reviewed by Drugs.com. Last updated on May 22, 2019.

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Indications and Usage for Dicyclomine

Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.

Dicyclomine Dosage and Administration

Dosage must be adjusted to individual patient needs.

Oral Dosage and Administration in Adults

The recommended initial dose is 20 mg four times a day.

After one week treatment with the initial dose, the dose may be increased to 40 mg four times a day unless side effects limit dosage escalation.

If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.

Dosage Forms and Strengths

Dicyclomine hydrochloride oral solution 10 mg/5 mL

Contraindications

Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [ see Use in Specific Populations (8.4)], nursing mothers [ see Use in Specific Populations (8.3)], and in patients with:

  • unstable cardiovascular status in acute hemorrhage
  • myasthenia gravis [ see Warnings and Precautions (5.4)]
  • glaucoma [ see Adverse Reactions (6.3) and Drug Interactions (7.1)]
  • obstructive uropathy [ see Warnings and Precautions (5.8)]
  • obstructive disease of the gastrointestinal tract [ see Warnings and Precautions (5.5)]
  • severe ulcerative colitis [ see Warnings and Precautions (5.7)]
  • reflux esophagitis

Warnings and Precautions

Cardiovascular Conditions

Dicyclomine hydrochloride needs to be used with caution in conditions characterized by tachyarrhythmia such as thyrotoxicosis, congestive heart failure and in cardiac surgery, where they may further accelerate the heart rate. Investigate any tachycardia before administration of Dicyclomine hydrochloride. Care is required in patients with coronary heart disease, as ischemia and infarction may be worsened, and in patients with hypertension [ see Adverse Reactions (6.3)].

Peripheral and Central Nervous System

The peripheral effects of Dicyclomine hydrochloride are a consequence of their inhibitory effect on muscarinic receptors of the autonomic nervous system. They include dryness of the mouth with difficulty in swallowing and talking, thirst, reduced bronchial secretions, dilatation of the pupils (mydriasis) with loss of accommodation (cycloplegia) and photophobia, flushing and dryness of the skin, transient bradycardia followed by tachycardia, with palpitations and arrhythmias, and difficulty in micturition, as well as reduction in the tone and motility of the gastrointestinal tract leading to constipation [ see Adverse Reactions (6)].

In the presence of high environmental temperature heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). It should also be used cautiously in patients with fever. If symptoms occur, the drug should be discontinued and supportive measures instituted. Because of the inhibitory effect on muscarinic receptors within the autonomic nervous system, caution should be taken in patients with autonomic neuropathy. Central nervous system (CNS) signs and symptoms include confusion, disorientation, short-term amnesia, hallucinations, dysarthria, ataxia, coma, euphoria, fatigue, insomnia, agitation and mannerisms, and inappropriate affect. Psychosis has been reported in sensitive individuals given anticholinergic drugs. These CNS signs and symptoms usually resolve within 12 to 24 hours after discontinuation of the drug.

Dicyclomine hydrochloride may produce drowsiness, dizziness or blurred vision. The patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work while taking Dicyclomine hydrochloride.

Myasthenia Gravis

With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis). It should not be given to patients with myasthenia gravis except to reduce adverse muscarinic effects of an anticholinesterase [ see Contraindications (4)].

Intestinal Obstruction

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or olostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful [ see Contraindications (4)].

Rarely development of Ogilvie’s syndrome (colonic pseudo-obstruction) has been reported. Ogilvie’s syndrome is a clinical disorder with signs, symptoms, and radiographic appearance of an acute large bowel obstruction but with no evidence of distal colonic obstruction.

Toxic Dilatation of Intestinemegacolon

Toxic dilatation of intestine and intestinal perforation is possible when anticholinergic agents are administered in patients with Salmonella dysentery.

Ulcerative Colitis

Caution should be taken in patients with ulcerative colitis. Large doses may suppress intestinal motility to the point of producing a paralytic ileus and the use of this drug may precipitate or aggravate the serious complication of toxic megacolon [ see Adverse Reactions (6.3)]. Dicyclomine hydrochloride is contraindicated in patients with severe ulcerative colitis [ see Contraindications (4)].

Prostatic Hypertrophy

Dicyclomine hydrochloride should be used with caution in patients with known or suspected prostatic enlargement, in whom prostatic enlargement may lead to urinary retention [ see Adverse Reactions (6.3)].

Hepatic and Renal Disease

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Dicyclomine hydrochloride should be used with caution in patients with known hepatic and renal impairment.

Geriatric Population

Dicyclomine hydrochloride should be used with caution in elderly who may be more susceptible to its adverse effects.

Adverse Reactions

The pattern of adverse effects seen with Dicyclomine is mostly related to its pharmacological actions at muscarinic receptors [ see Clinical Pharmacology (12)]. They are a consequence of the inhibitory effect on muscarinic receptors within the autonomic nervous system. These effects are dose-related and are usually reversible when treatment is discontinued.

The most serious adverse reactions reported with Dicyclomine hydrochloride include cardiovascular and central nervous system symptoms [ see Warnings and Precautions (5.2,5.3)].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure in controlled clinical trials involving over 100 patients treated for functional bowel/irritable bowel syndrome with Dicyclomine hydrochloride at initial doses of 160 mg daily (40 mg four times a day).

In these trials most of the side effects were typically anticholinergic in nature and were reported by 61% of the patients. Table 1 presents adverse reactions ( MedDRA 13.0 preferred terms) by decreasing order of frequency in a side-by-side comparison with placebo.

Table 1: Adverse reactions experienced in controlled clinical trials with decreasing order of frequency

MedDRA Preferred Term

Dicyclomine Hydrochloride (40 mg four times a day) %

Placebo %

Dry Mouth

33

5

Dizziness

40

5

Vision blurred

27

2

Nausea

14

6

Somnolence

9

1

Asthenia

7

1

Nervousness

6

2

Nine percent (9%) of patients were discontinued from Dicyclomine hydrochloride because of one or more of these side effects (compared with 2% in the placebo group). In 41% of the patients with side effects, side effects disappeared or were tolerated at the 160 mg daily dose without reduction. A dose reduction from 160 mg daily to an average daily dose of 90 mg was required in 46% of the patients with side effects who then continued to experience a favorable clinical response; their side effects either disappeared or were tolerated.

Postmarketing Experience

The following adverse reactions, presented by system organ class in alphabetical order, have been identified during post approval use of Dicyclomine hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Cardiac disorders: palpitations, tachyarrhythmias
  • Eye disorders: cycloplegia, mydriasis, vision blurred
  • Gastrointestinal disorders: abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, nausea, vomiting
  • General disorders and administration site conditions: fatigue, malaise
  • Immune system disorders: drug hypersensitivity including face oedema, angioedema, anaphylactic shock
  • Nervous system disorders: dizziness, headache, hallucinations, insomnia, somnolence, syncope
  • Psychiatric disorders: confusional state, nervousness
  • Reproductive system and breast disorders: suppressed lactation
  • Respiratory, thoracic and mediastinal disorders: dyspnoea, nasal congestion
  • Skin and subcutaneous tissue disorder: dermatitis allergic, erythema, rash

Adverse Reactions Reported with Similar Drugs with Anticholinergic/Antispasmodic Action

Gastrointestinal: anorexia

Central Nervous System: tingling, numbness, dyskinesia, speech disturbance, insomnia

Peripheral Nervous System: With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).

Ophthalmologic: diplopia, increased ocular tension

Dermatologic/Allergic: urticaria, itching, and other dermal manifestations

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Genitourinary: urinary hesitancy, urinary retention in patients with prostatic hypertrophy

Cardiovascular: hypertension

Respiratory: apnea

Other: decreased sweating, sneezing, throat congestion, impotence

Drug Interactions

Antiglaucoma Agents

Anticholinergics antagonize the effects of antiglaucoma agents. Anticholinergic drugs in the presence of increased intraocular pressure may be hazardous when taken concurrently with agents such as corticosteroids. Use of Dicyclomine hydrochloride in patients with glaucoma is not recommended [ see Contraindications (4)].

Other Drugs with Anticholinergic Activity

The following agents may increase certain actions or side effects of anticholinergic drugs including Dicyclomine hydrochloride: amantadine, antiarrhythmic agents of Class I (e.g., quinidine), antihistamines, antipsychotic agents (e.g., phenothiazines), benzodiazepines, MAO inhibitors, narcotic analgesics (e.g., meperidine), nitrates and nitrites, sympathomimetic agents, tricyclic antidepressants, and other drugs having anticholinergic activity.

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Other Gastrointestinal Motility Drugs

Interaction with other gastrointestinal motility drugs may antagonize the effects of drugs that alter gastrointestinal motility, such as metoclopramide.

Effect of Antacids

Because antacids may interfere with the absorption of anticholinergic agents including dicycolomine hydrochloride, simultaneous use of these drugs should be avoided.

Effect on Absorption of Other Drugs

Anticholinergic agents may affect gastrointestinal absorption of various drugs by affecting on gastrointestinal motility, such as slowly dissolving dosage forms of digoxin; increased serum digoxin concentration may result.

Effect on Gastric Acid Secretion

The inhibiting effects of anticholinergic drugs on gastric hydrochloric acid secretion are antagonized by agents used to treat achlorhydria and those used to test gastric secretion.

USE IN SPECIFIC POPULATIONS

Pregnancy

Teratogenic Effects

Pregnancy Category B

Adequate and well-controlled studies have not been conducted with Dicyclomine hydrochloride in pregnant women at the recommended doses of 80 to 160 mg/day. However, epidemiologic studies did not show an increased risk of structural malformations among babies born to women who took products containing Dicyclomine hydrochloride at doses up to 40 mg/day during the first trimester of pregnancy. Reproduction studies have been performed in rats and rabbits at doses up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of harm to the fetus due to Dicyclomine. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Dicyclomine hydrochloride is contraindicated in women who are human milk feeding. Dicyclomine hydrochloride is excreted in human milk. Because of the potential for serious adverse reactions in human breastfed infants from Dicyclomine hydrochloride, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother [ see Use in Specific Populations (8.4)].

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Dicyclomine hydrochloride is contraindicated in infants less than 6 months of age [ see Contrainidications (4)]. There are published cases reporting that the administration of Dicyclomine hydrochloride to infants has been followed by serious respiratory symptoms (dyspnea, shortness of breath, breathlessness, respiratory collapse, apnea and asphyxia), seizures, syncope, pulse rate fluctuations, muscular hypotonia, and coma, and death, however; no causal relationship has been established.

Geriatric Use

Clinical studies of Dicyclomine hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range in adults, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Renal Impairment

Effects of renal impairment on PK, safety and efficacy of Dicyclomine hydrochloride have not been studied. Dicyclomine hydrochloride drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Dicyclomine hydrochloride should be administered with caution in patients with renal impairment.

Hepatic Impairment

Effects of renal impairment on PK, safety and efficacy of Dicyclomine hydrochloride have not been studied. Dicyclomine hydrochloride should be administered with caution in patients with hepatic impairment.

Overdosage

In case of an overdose, patients should contact a physician, poison control center (1-800-222-1222), or emergency room.

The signs and symptoms of overdosage include: headache; nausea; vomiting; blurred vision; dilated pupils; hot, dry skin; dizziness; dryness of the mouth; difficulty in swallowing; and CNS stimulation including convulsion. A curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).

One reported event included a 37-year-old who reported numbness on the left side, cold fingertips, blurred vision, abdominal and flank pain, decreased appetite, dry mouth, and nervousness following ingestion of 320 mg daily (four 20 mg tablets four times daily). These events resolved after discontinuing the Dicyclomine.

The acute oral LD 50 of the drug is 625 mg/kg in mice.

The amount of drug in a single dose that is ordinarily associated with symptoms of overdosage or that is likely to be life-threatening, has not been defined. The maximum human oral dose recorded was 600 mg by mouth in a 10-month-old child and approximately 1500 mg in an adult, each of whom survived. In three of the infants who died following administration of Dicyclomine hydrochloride [ see Warnings and Precautions (5)], the blood concentrations of drug were 200, 220, and 505 ng/mL.

It is not known if Dicyclomine hydrochloride is dialyzable.

Treatment should consist of gastric lavage, emetics, and activated charcoal. Sedatives (e.g., short-acting barbiturates, benzodiazepines) may be used for management of overt signs of excitement. If indicated, an appropriate parenteral cholinergic agent may be used as an antidote.

Dicyclomine Description

Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following dosage form:

  • Dicyclomine Hydrochloride Oral Solution, USP contains 10 mg Dicyclomine hydrochloride USP in each 5 mL (1 teaspoonful). Dicyclomine hydrochloride oral solution also contains inactive ingredients glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol solution, sucrose with D&C Red #33, FD&C Blue #1, FD&C Red #40, FD&C Yellow #6 as coloring and natural and articial tropical fruit punch flavoring.

Dicyclomine hydrochloride is [bicyclohexyl]-1‑carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride, with a molecular formula of C 19H 35NO 2•HCl and the following structural formula:

Molecular weight: 345.95

Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether.

Dicyclomine - Clinical Pharmacology

Mechanism of Action

Dicyclomine relieves smooth muscle spasm of the gastrointestinal tract. Animal studies indicate that this action is achieved via a dual mechanism:

  • a specific anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites with approximately 1/8 the milligram potency of atropine ( in vitro, guinea pig ileum); and
  • a direct effect upon smooth muscle (musculotropic) as evidenced by Dicyclomine’s antagonism of bradykinin- and histamine-induced spasms of the isolated guinea pig ileum.

Atropine did not affect responses to these two agonists. In vivo studies in cats and dogs showed Dicyclomine to be equally potent against acetylcholine (ACh)- or barium chloride (BaCl 2)-induced intestinal spasm while atropine was at least 200 times more potent against effects of ACh than BaCl 2. Tests for mydriatic effects in mice showed that Dicyclomine was approximately 1/500 as potent as atropine; antisialagogue tests in rabbits showed Dicyclomine to be 1/300 as potent as atropine.

Pharmacodynamics

Dicyclomine hydrochloride can inhibit the secretion of saliva and sweat, decrease gastrointestinal secretions and motility, cause drowsiness, dilate the pupils, increase heart rate, and depress motor function.

Pharmacokinetics

Absorption and Distribution

In man, Dicyclomine is rapidly absorbed after oral administration, reaching peak values within 60 to 90 minutes. Mean volume of distribution for a 20 mg oral dose is approximately 3.65 L/kg suggesting extensive distribution in tissues.

Elimination

The metabolism of Dicyclomine was not studied. The principal route of excretion is via the urine (79.5% of the dose). Excretion also occurs in the feces, but to a lesser extent (8.4%). Mean half-life of plasma elimination in one study was determined to be approximately 1.8 hours when plasma concentrations were measured for 9 hours after a single dose. In subsequent studies, plasma concentrations were followed for up to 24 hours after a single dose, showing a secondary phase of elimination with a somewhat longer half-life.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been conducted to evaluate the carcinogenic potential of Dicyclomine. In studies in rats at doses of up to 100 mg/kg/day, Dicyclomine produced no deleterious effects on breeding, conception, or parturition.

Clinical Studies

In controlled clinical trials involving over 100 patients who received drug, 82% of patients treated for functional bowel/irritable bowel syndrome with Dicyclomine hydrochloride at initial doses of 160 mg daily (40 mg four times daily) demonstrated a favorable clinical response compared with 55% treated with placebo (p<0.05).

How Supplied/Storage and Handling

Dicyclomine hydrochloride oral solution is supplied as a pinkish orange, tropical fruit punch-flavored syrup in bottles of 473 mL (16 fl. oz.). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from excessive heat. Dispense in a tight container with a child-resistant closure.

Patient Counseling Information

Use in Infants

Inform parents and caregivers not to administer Dicyclomine hydrochloride in infants less than 6 months of age [ see Use in Specific Populations (8.4)].

Use in Nursing Mothers

Advise lactating women that Dicyclomine hydrochloride should not be used while human milk feeding their infants [ see Use in Specific Populations (8.3,8.4)].

Peripheral and Central Nervous System

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In the presence of a high environmental temperature, heat prostration can occur with Dicyclomine hydrochloride use (fever and heat stroke due to decreased sweating). If symptoms occur, the drug should be discontinued and a physician contacted. Dicyclomine hydrochloride may produce drowsiness or blurred vision. The patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or to perform hazardous work while taking Dicyclomine hydrochloride [ see Warnings and Precautions (5.3)].

Distributed by:

Par Pharmaceutical

Chestnut Ridge, NY 10977

Code 1214A00

Rev. 06/17

Dicyclomine HYDROCHLORIDE
Dicyclomine hydrochloride solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0603-1161
Route of AdministrationORALDEA Schedule
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dicyclomine HYDROCHLORIDE (Dicyclomine)Dicyclomine HYDROCHLORIDE10 mg in 5 mL
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
GLYCERIN
METHYLPARABEN
PROPYLENE GLYCOL
PROPYLPARABEN
SORBITOL
SUCROSE
WATER
Product Characteristics
ColorpinkScore
ShapeSize
FlavorFRUIT PUNCHImprint Code
Contains
Packaging
#Item CodePackage Description
1NDC:0603-1161-58473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04016906/23/2005
Par Pharmaceutical

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