Children's TYLENOL® Suspension Liquid and Meltaways

Children's TYLENOL® Suspension Liquid and Meltaways

Use only as directed.

Description/Ingredients

Children's TYLENOL® Suspension Liquid is stable, alcohol-free, cherry blast-flavored and red in color, bubblegum yum-flavored and pink in color, grape splash-flavored and purple in color, or very berry strawberry-flavored and red in color. Each 5 mL (one teaspoonful) contains 160 mg acetaminophen. Each Children's TYLENOL® Meltaway contains 80 mg acetaminophen in a grape punch or bubblegum burst.

Children's TYLENOL® Suspension Liquid and Meltaways

Use only as directed.

Actions

Acetaminophen is a clinically proven analgesic/antipyretic. Acetaminophen is thought to produce 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.

Children's TYLENOL® Suspension Liquid and Meltaways

Use only as directed.

Uses

Children's TYLENOL® Suspension Liquid and Meltaways:

  • temporarily relieves minor aches and pains due to:
    the common cold, flu, headache, sore throat, toothache
  • temporarily reduces fever
Children's TYLENOL® Suspension Liquid and Meltaways

Use only as directed.

Dosing

Children's TYLENOL® Suspension Liquid and Meltaways

  • This product does not contain directions or complete warnings for adult use.

TABLE 1 Children's Tylenol® Dosing Chart

TABLE 1 Children's Tylenol® Dosing Chart
Children's TYLENOL® Suspension Liquid and Meltaways

Use only as directed.

Warnings

Children's TYLENOL® Suspension Liquid and Meltaways

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if your child has liver disease

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

Stop use and ask a doctor if:

  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information:

Children's Tylenol® Suspension Liquid and Meltaways:

  • each teaspoon contains: sodium 2 mg (excludes Dye-Free Cherry)
  • store between 20-25ºC (68-77ºF)
Children's TYLENOL® Suspension Liquid and Meltaways

Use only as directed.

PROFESSIONAL INFORMATION: OVERDOSAGE INFORMATION

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/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 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)

For additional emergency information, please contact your local poison control center.

Children's TYLENOL® Suspension Liquid and Meltaways

Use only as directed.

How Supplied

Children's TYLENOL® Suspension Liquid

cherry
bubb
grape
strawberry
tdf

Children's TYLENOL® Meltaways

bubble
grape

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

Children's TYLENOL® Suspension Liquid and Meltaways

Use only as directed.

Inactive Ingredients

Children's TYLENOL® Suspension Liquid: anhydrous citric acid, butylparaben, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum. In addition to the above ingredients cherry blast-flavored suspension contains FD&C red #40, bubblegum-yum-flavored suspension contains D&C red #33 and FD&C red #40, grape splash-flavored suspension contains D&C red #33 and FD&C blue #1 and very berry strawberry-flavored suspension contains FD&C red #40.

Children's TYLENOL® Meltaways: Grape-Punch-Flavored: cellulose acetate, citric acid, crospovidone, dextrose, D&C red #7, D&C red #30, FD&C blue #1, flavors, magnesium stearate, povidone, sucralose. Bubblegum Burst-Flavored: anhydrous citric acid, cellulose acetate, crospovidone, D&C red #7, calcium lake, dextrose excipient, flavor, magnesium stearate, povidone, sucralose.

This website contains the most current Drug Facts labeling information, and may differ from labels on product packaging you may have. If there are any differences between this website labeling and product packaging labeling, this website labeling should be regarded as the most current.