Product information for all dosage forms of CHILDREN'S TYLENOL acetaminophen have been combined under this heading

Infants' TYLENOL® Grape Concentrated Drops are stable, alcohol-free, grape-flavored and purple in color. Infants' TYLENOL® Cherry Concentrated Drops are stable, alcohol-free, 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.

ACTIONS

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.

USES

Children's TYLENOL® Soft-Chews Chewable Tablets, Suspension Liquid and Infants' TYLENOL® Concentrated Drops: For the reduction of fever. For the temporary relief of minor aches and pains associated with a cold, flu, headache, sore throat, immunizations, toothache.

DIRECTIONS

If possible, use weight to dose; otherwise use age. All dosages may be repeated every 4 hours, if needed. Do not use more than 5 times a day. Under 2 years (under 24 lbs), consult a physician. Children's TYLENOL® Soft-Chews Chewable Tablets: Chew tablets before swallowing. Children's TYLENOL® Soft-Chews Chewable Tablets are not the same concentration as Junior Strength Tylenol® Chewable Tablets or Caplets. For accurate dosing follow dosing instructions on label. 2-3 years (24-35 lbs): 2 tablets; 4-5 years (36-47 lbs): 3 tablets; 6-8 years (48-59 lbs): 4 tablets; 9-10 years (60-71 lbs): 5 tablets; 11 years (72-95 lbs): 6 tablets.

Children's TYLENOL® Suspension Liquid: Children's Tylenol® Liquids are less concentrated than Infants' Tylenol® Concentrated Drops. For accurate dosing follow dosing instructions on label. This product has been specifically designed for use with the enclosed measuring cup. Use only enclosed measuring cup to dose this product. Do not use any other dosing device. 2-3 years (24-35 lbs): 1 teaspoonful; 4-5 years (36-47 lbs): 1 1 / 2 teaspoonfuls; 6-8 years (48-59 lbs): 2 teaspoonfuls; 9-10 years (60-71 lbs): 2 1 / 2 teaspoonfuls; 11 years (72-95 lbs): 3 teaspoonfuls. Infants' TYLENOL® Concentrated Drops: Infants' Tylenol® Drops are more concentrated than Children's Tylenol® Liquids. For accurate dosing follow dosing instructions on label. This product has been specifically designed for use only with enclosed dropper. Do not use any other dosing device with this product. 2-3 years (24-35 lbs): 2 dropperfuls (2 × 0.8 mL).

Professional Dosage Schedule: Children's TYLENOL® Suspension Liquid: Children's Tylenol® Liquids are less concentrated than Infants' Tylenol® Concentrated Drops. For accurate dosing follow dosing instructions on label. This product has been specifically designed for use with the enclosed measuring cup. Use only enclosed measuring cup to dose this product. Do not use any other dosing device. If possible, use weight to dose; otherwise use age. 4-11 months (12-17 lbs): 1 / 2 teaspoonful; 12-23 months (18-23 lbs): 3 / 4 teaspoonful. Infants' TYLENOL® Concentrated Drops: Infants' Tylenol® Drops are more concentrated than Children's Tylenol® Liquids. For accurate dosing follow dosing instructions on label. This product has been specifically designed for use only with enclosed dropper. Do not use any other dosing device with this product. If possible, use weight to dose; otherwise use age. 0-3 months (6-11 lbs): 0.4 mL; 4-11 months (12-17 lbs): 0.8 mL; 12-23 months (18-23 lbs): 1.2 mL. All dosages may be repeated every 4 hours, if needed. Do not use more than 5 times a day.

PRECAUTIONS

If a rare sensitivity reaction occurs, the drug should be discontinued.

Children's TYLENOL® Soft-Chew Chewable Tablets, Suspension Liquid and Infants' TYLENOL® Concentrated Drops:   

Do Not Use:

Stop Using This Product and Ask a Doctor If:

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.

NOTE :  In addition to the above:

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 6 mg per tablet, fruit contains 6 mg per tablet.

PROFESSIONAL INFORMATION

OVERDOSAGE INFORMATION

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/kg has 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 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).

Inactive Ingredients:    Children's TYLENOL® Soft-Chews Fruit Flavored Chewable Tablets:   Aspartame, Cellulose, Citric Acid, D&C Red #7, Flavors, D&C Red #7, Flavors, Magnesium Stearate, Mannitol. May contain Ethylcellulose or Cellulose Acetate and Povidone.

Children's TYLENOL® Soft-Chews Grape Flavored Chewable Tablets: Aspartame, Cellulose, Citric Acid, D&C Red #7, D&C Red #30, FD&C Blue #1, Flavors, Magnesium Stearate, Mannitol. May contain Ethylcellulose or Cellulose Acetate and Povidone.

Children's TYLENOL® Soft-Chews Bubble Gum Flavored Chewable Tablets: Aspartame, Cellulose, D&C Red #7, Flavors, Magnesium Stearate, Mannitol. May contain Ethylcellulose or Cellulose Acetate and Povidone.

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.

Infants' TYLENOL® Cherry Concentrated Drops: Butylparaben, Cellulose, Citric Acid, Corn Syrup, FD&C Red #40, Flavors, Glycerin, Propylene Glycol, Purified Water, Sodium Benzoate, Sorbitol, Xanthan Gum.

Infants' TYLENOL® Grape Concentrated Drops: 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.

HOW SUPPLIED

Soft-Chew 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). Bubble gum and fruit: Store at room temperature; grape: store at room temperature and keep product away from direct light. 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. Concentrated drops (purple-colored grape): bottles of 1 / 2 oz (15 mL) and 1 oz (30 mL); (red-colored cherry): bottles of 1 / 2 oz and 1 oz, each with calibrated plastic dropper. Store at room temperature.

All packages listed above have child-resistant safety caps or blisters.

PRODUCT PHOTO(S):

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug' identity should be verified by chemical analysis.

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