Your browser does not support JavaScript! CHILDRENS PAIN RELIEF (ACETAMINOPHEN) TABLET, CHEWABLE [DOLGENCORP, LLC]
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RxNorm Names

CHILDRENS PAIN RELIEF (acetaminophen) tablet, chewable
[DOLGENCORP, LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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
  • sorethroat
  • 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 controlled room temperature 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

Product Packaging

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

DG™

health

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

For Ages 2-11

SEE NEW WARNINGS INFORMATION

Children's

Rapid Melts

Acetaminophen

Pain Reliever / Fever Reducer

• Ibuprofen free

• Aspirin free

Bubble Gum Flavor

DG Quality Guaranteed

30

80 mg Tablets

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

50844       REV0410B44701

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSIONS RIDGE

GOODLETTSVILLE, TN 37073

Product Packaging

Product Packaging

CHILDRENS PAIN RELIEF 
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55910-447
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 
DEXTROSE 
ETHYLCELLULOSES 
MAGNESIUM STEARATE 
MANNITOL 
POVIDONE 
STEARIC ACID 
SUCRALOSE 
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize13mm
FlavorBUBBLE GUMImprint Code 44;447
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-447-011 in 1 CARTON
130 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34302/03/2005
Labeler - DOLGENCORP, LLC (068331990)

Revised: 3/2011
 
DOLGENCORP, LLC

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