Childrens Pain Reliever description, usages, side effects, indications, overdosage, supplying and lots more!

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Childrens Pain Reliever

H E B

HEB 44-447




FULL PRESCRIBING INFORMATION

Acetaminophen 80 mg

Pain reliever/fever reducer

  • temporarily relieves minor aches and pains due to:
    • the common cold
    • headache
    • flu
    • sorethroat
    • toothache
  • temporarily reduces fever

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.

  • 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
  • liver disease
  • taking the blood thinning drug warfarin
  • do not exceed recommended dosage
  • 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

These could be signs of a serious condition.

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. Quick medical attention is critical even if you do not notice any signs or symptoms.

  • this product does not contain directions or complete warning for adult use
  • find the right dose on chart. If possible, use weight to dose; otherwise, use age.
  • dissolve in mouth or chew before swallowing
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor
 Weight (lb)  Age (yr)  Tablets
 under 24  under 2  Ask a doctor
 24-35  2-3  2
 36-47  4-5  3
 48-59  6-8  4
 60-71  9-10  5
 72-95  11  6
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

citric acid, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrose, ethylcellulose, flavors, magnesium stearate, mannitol, polyethylene, povidone, stearic acid, sucralose

1-800-426-9391

Compare to Tylenol® Meltaways ® active ingredients*

NDC 37808-447-01

H-E-B®

CHILDREN'S PAIN RELIEVER
Pain Reliever/Fever Reducer

ACETAMINOPHEN 80 mg
Rapid Melts
• Ages 2-6
• Ibuprofen & Aspirin Free

Bubble Gum Flavor

30 Tablets

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Meltaways®.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Childrens Pain Reliever
HEB 44-447

Childrens Pain Reliever

Acetaminophen TABLET, ORALLY DISINTEGRATING

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37808-447
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 80 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
D&C RED NO. 27
D&C RED NO. 30
DEXTROSE
ETHYLCELLULOSES
MAGNESIUM STEARATE
mannitol
POVIDONES
STEARIC ACID
Sucralose

Product Characteristics

Color Size Imprint Code Shape
PINK 13 mm 44;447 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE, PLASTIC
2 NDC:37808-447-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2005-02-03


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Be sure to consult your doctor before taking any medication!
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