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Pain Relief Childrens by CVS Pharmacy

Dosage form: tablet, chewable
Ingredients: ACETAMINOPHEN 80mg
Labeler: CVS Pharmacy
NDC Code: 59779-447

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.

CVS 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:
    • headache
    • the common cold
    • flu
    • toothache
    • sore throat
  • 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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • chew before swallowing; this product will soften in mouth for ease of chewing
  • 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 24Under 2Ask a doctor
24-352-32
36-474-53
48-596-84
60-719-105
72-9511

6

*or as directed by a doctor

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

Inactive ingredients

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

Questions or comments?

1-800-426-9391

Principal Display Panel

♥CVS Health

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

Chewable Tablets

NDC 59779-447-01

Children's
Pain Relief
ACETAMINOPHEN, 80 mg

Pain reliever, Fever reducer
Ages 2-6

• Aspirin free
• Ibuprofen free

30 TABLETS

Bubble Gum Flavor
Actual Product Size on Side Panel

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

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Tylenol® Meltaways®.
50844      REV0416A44701

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2016 CVS/pharmacy   CVS.com®
1-800-SHOP CVS
V-11112

√ CVS Quality
Money Back Guarantee

CVS 44-447

PAIN RELIEF  CHILDRENS
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-447
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 
STEARIC ACID 
SUCRALOSE 
DEXTROSE 
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize13mm
FlavorBUBBLE GUMImprint Code44;447
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-447-011 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 - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(59779-447)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(59779-447)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(59779-447)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(59779-447)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(59779-447)

 
CVS Pharmacy

← See all Pain Relief Childrens brands

Medically reviewed on Jan 29, 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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