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Childrens Pain Reliever by H E B

Dosage form: tablet, chewable
Ingredients: ACETAMINOPHEN 80mg
Labeler: H E B
NDC Code: 37808-447

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

HEB 44-447-Delisted

Active ingredient  (in each tablet)

Acetaminophen 80 mg

Purpose

Pain reliever/fever reducer

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

Warnings

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.

When using this product

do not exceed recommended dosage.

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

These could be signs of a serious condition.

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

Directions
  • 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

Other information
  • store at 25ºC (77ºF); excursions permitted 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

1-800-426-9391

Principal Display Panel

Compare to Children's Tylenol® Meltaways® active ingredient*

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

ACTUAL SIZE

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

50844     ORG041244701

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

HEB 44-447

CHILDRENS PAIN RELIEVER 
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-447
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN80 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
D&C RED NO. 27 
D&C RED NO. 30 
ETHYLCELLULOSE, UNSPECIFIED 
MAGNESIUM STEARATE 
MANNITOL 
POVIDONE 
STEARIC ACID 
SUCRALOSE 
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize13mm
FlavorBUBBLE GUMImprint Code44;447
Contains    
Packaging
#Item CodePackage Description
1NDC:37808-447-011 BOTTLE, PLASTIC in 1 CARTON
130 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34302/03/200511/28/2020
Labeler - H E B (007924756)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(37808-447)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(37808-447)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(37808-447)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(37808-447)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(37808-447)

 
H E B

← See all Childrens Pain Reliever brands

Medically reviewed on Jan 25, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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