Infants' TYLENOL® Concentrated Drops are stable, alcohol-free, grape-flavored and purple in color or cherry-flavored and red in color. Each 1.6 mL (2 dropperfuls) contains 160 mg acetaminophen. Infants' TYLENOL® Concentrated Drops features the SAFE-TY-LOCK™ Bottle. The SAFE-TY-LOCK™ Bottle has a unique safety barrier inside the bottle which helps make administration easier. The integrated dropper promotes proper administration. The innovative design eliminates excess product on dropper. The star-shaped barrier inside the bottle minimizes spills and discourages pouring into a spoon. Children's TYLENOL® Suspension Liquid is stable, alcohol-free, cherry-flavored and red in color, or bubble gum-flavored and pink in color, or grape-flavored and purple in color. Each 5 mL (one teaspoonful) contains 160 mg acetaminophen. Each Children's TYLENOL® Soft Chews Chewable Tablet contains 80 mg acetaminophen in a grape, bubble gum, or fruit flavor. Each Junior Strength TYLENOL® Soft Chews Chewable Tablet contains 160 mg acetaminophen in a grape or fruit-flavored chewable tablet.
Acetaminophen is a clinically proven analgesic/antipyretic. Acetaminophen produces analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat-regulating center. Acetaminophen is equal to aspirin in analgesic and antipyretic effectiveness and it is unlikely to produce many of the side effects associated with aspirin and aspirin-containing products.
Infants' TYLENOL® Concentrated Drops: temporarily:
Children's TYLENOL® Suspension Liquid and Children's TYLENOL® Soft Chews Chewable Tablets: For the reduction of fever. For the temporary relief of minor aches and pains associated with a cold, flu, headache, sore throat, immunizations, toothache. Junior Strength TYLENOL® Soft Chews Chewable Tablets: For the temporary relief of minor aches and pains associated with: a cold, flu, headache, muscle aches, sprains, overexertion. For the reduction of fever.
See Table 1: Children's Tylenol Dosing Chart on pg. __
If a rare sensitivity reaction occurs, the drug should be discontinued.
Infant' TYLENOL® Concentrated Drops:
Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use: with any other product containing acetaminophen
When using this product
Stop use and ask a doctor if
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
Children's TYLENOL® Suspension Liquid, Children's TYLENOL® Soft Chews Chewable Tablets and Junior Strength TYLENOL® Soft Chews Chewable Tablets:
Do Not Use:
Do not exceed recommended dose. Taking more than the recommended dose (overdose) may not provide more relief and could cause serious health problems. Keep this and all drugs out of the reach of children. In case of accidental overdose, contact a physician or poison control center immediately. Prompt medical attention is critical even if you do not notice any signs or symptoms.
Infants' TYLENOL® Concentrated Drops: Do not use if plastic carton wrap or bottle wrap imprinted "Safety Seal®" is broken or missing.
Children's TYLENOL® Suspension Liquid: Do not use if plastic carton wrap, bottle wrap, or foil inner seal imprinted "Safety Seal®" is broken or missing. Children's TYLENOL® Soft Chews Chewable Tablets: Do not use if carton is opened or if neck wrap or foil inner seal imprinted "Safety Seal®" is broken or missing. Phenylketonurics: grape contains phenylalanine 5 mg per tablet, bubble gum contains phenylalanine 6 mg per tablet, fruit contains phenylalanine 6 mg per tablet. Junior Strength TYLENOL® Soft Chews Chewable Tablets: Phenylketonurics: grape contains phenylalanine 10 mg per tablet, fruit contains phenylalanine 12 mg per tablet. Do not use if carton is opened or if blister unit is broken.
Professional Information:
Overdosage Information
for all Infants', Children's & Junior Strength Tylenol® Products
ACETAMINOPHEN Acetaminophen in massive overdosage may cause hepatic toxicity in some patients. In adults and adolescents (>/= 12 years of age), hepatic toxicity may occur following ingestion of greater than 7.5 to 10 grams over a period of 8 hours or less. Fatalities are infrequent (less than 3-4% of untreated cases) and have rarely been reported with overdoses of less than 15 grams. In children (<12 years of age), an acute overdosage of less than 150 mg/kghas not been associated with hepatic toxicity. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours postingestion. In adults and adolescents, any individual presenting with an unknown amount of acetaminophen ingested or with a questionable or unreliable history about the time of ingestion should have a plasma acetaminophen level drawn and be treated with N -acetylcysteine. For full prescribing information, refer to the N -acetylcysteine package insert. Do not await results of assays for plasma acetaminophen levels before initiating treatment with N -acetylcysteine. The following additional procedures are recommended: Promptly initiate gastric decontamination of the stomach. A plasma acetaminophen assay should be obtained as early as possible, but no sooner than four hours following ingestion. If an acetaminophen extended release product is involved, it may be appropriate to obtain an additional plasma acetaminophen level 4-6 hours following the initial acetaminophen level. If either acetaminophen level plots above the treatment line on the acetaminophen overdose nomogram, N -acetylcysteine treatment should be continued for a full course of therapy. Liver function studies should be obtained initially and repeated at 24-hour intervals. Serious toxicity or fatalities have been extremely infrequent following an acute acetaminophen overdose in young children, possibly because of differences in the way they metabolize acetaminophen. In children, the maximum potential amount ingested can be more easily estimated. If more than 150 mg/kg or an unknown amount was ingested, obtain a plasma acetaminophen level as soon as possible, but no sooner than 4 hours following ingestion. If an acetaminophen extended release product is involved, it may be appropriate to obtain an additional plasma acetaminophen level 4-6 hours following the initial acetaminophen level. If either acetaminophen level plots above the treatment line on the acetaminophen overdose nomogram, N -acetylcysteine treatment should be initiated and continued for a full course of therapy. If an assay cannot be obtained and the estimated acetaminophen ingestion exceeds 150 mg/kg, dosing with N -acetylcysteine should be initiated and continued for a full course of therapy. For additional emergency information, call your regional poison center or call the Rocky Mountain Poison Center toll-free, (1-800-525-6115).
Our pediatric Tylenol® combination products contain active ingredients in addition to acetaminophen. The following is basic overdose information regarding those ingredients.
CHLORPHENIRAMINE: Chlorpheniramine toxicity should be treated as you would an anthihistamine/anticholinergic overdose and is likely to be present within a few hours after acute ingestion.
DEXTROMETHORPHAN: Acute dextromethorphan overdose usually does not result in serious signs and symptoms unless massive amounts have been ingested. Signs and symptoms of a substantial overdose may include nausea and vomiting, visual disturbances, CNS disturbances and urinary retention.
DIPHENHYDRAMINE: Diphenhydramine toxicity should be treated as you would an antihistamine/anticholinergic overdose and is likely to be present within a few hours after acute ingestion.
PSEUDOEPHEDRINE: Symptoms from pseudoephedrine overdose consist most often of mild anxiety, tachycardia and/or mild hypertension. Symptoms usually appear within 4 to 8 hours of ingestion and are transient, usually requiring no treatment.
For additional emergency information, please contact your local poison control center.
Infants' TYLENOL® Concentrated Drops: Cherry-Flavored: butylparaben, cellulose, citric acid, corn syrup, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, xanthan gum. Grape-Flavored: butylparaben, cellulose, citric acid, corn syrup, D&C red #33, FD&C blue #1, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, xanthan gum.
Children's TYLENOL® Suspension Liquid: Butylparaben, Cellulose, Citric Acid, Corn Syrup, Flavors, Glycerin, Propylene Glycol, Purified Water, Sodium Benzoate, Sorbitol, Xanthan Gum. In addition to the above ingredients cherry-flavored suspension contains FD&C Red #40, bubble gum-flavored suspension contains D&C Red #33 and FD&C Red #40, and grape-flavored suspension contains D&C Red #33 and FD&C Blue #1.
Junior Strength TYLENOL® Soft Chews Chewable Tablets: Fruit-Flavored: Aspartame, Cellulose, Citric Acid, D&C Red #7, Flavors, Magnesium Stearate, Mannitol, Sodium Starch Glycolate. May contain Ethylcellulose or Cellulose Acetate and Povidone. Grape-Flavored: Aspartame, Cellulose, Citric Acid, D&C Red #7, D&C Red #30, FD&C Blue #1, Flavors, Magnesium Stearate, Mannitol, Sodium Starch Glycolate. May contain Ethylcellulose or Cellulose Acetate and Povidone.
Children's TYLENOL® Soft Chews Chewable Tablets: Fruit-Flavored: Aspartame, Cellulose, Citric Acid, D&C Red #7, Flavors, Magnesium Stearate, Mannitol, Sodium Starch Glycolate. May contain Ethylcellulose or Cellulose Acetate and Povidone. Grape-Flavored: Aspartame, Cellulose, Citric Acid, D&C Red #7, D&C Red #30, FD&C Blue #1, Flavors, Magnesium Stearate, Mannitol, Sodium Starch Glycolate. May contain Ethylcellulose or Cellulose Acetate and Povidone. Bubble Gum-Flavored: Aspartame, Cellulose, D&C Red #7, Flavors, Magnesium Stearate, Mannitol, Sodium Starch Glycolate. May contain Ethylcellulose or Cellulose Actate and Povidone.
Infants' TYLENOL® Concentrated Drops: (purple-colored grape): bottles of ½ oz (15 mL) and 1 oz (30 mL); (red-colored cherry): bottles of ½ oz and 1 oz, each with calibrated plastic dropper. Store at room temperature.
Children's TYLENOL® Suspension Liquid: (red-colored cherry): bottles of 2 and 4 fl oz. (pink-colored bubble gum and purple-colored grape): bottles of 4 fl. oz. Store at room temperature.
Children's TYLENOL® Soft Chews Chewable Tablets: (pink-colored fruit, purple-colored grape, pink-colored bubble gum, scored, imprinted "TY80"). Bottles of 30 and also blister packaged 60's and 96's (fruit). Store at room temperature.
Junior Strength TYLENOL® Soft Chews Chewable Tablets: (purple-colored grape or pink-colored fruit, imprinted "TY 160") Package of 24. Fruit: Store at room temperature. Avoid excessive heat: 40°C (104°F); Grape: Store at room temperature. Avoid excessive heat: 40°C (104°F). Keep product away from direct light. All packages listed above are safety sealed and use child-resistant safety caps or blisters.
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