CHILDRENS PAIN RELIEF- acetaminophen tablet, chewable 
CVS Pharmacy

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.

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CVS 44-452

Active ingredient (in each tablet)

Acetaminophen 80 mg

Purpose

Pain reliever/fever reducer

Uses

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

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 (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

  • do not give more than directed (see overdose warning)
  • this product does not contain directions or complete warnings for adult use
  • 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) Dose (tablets)*
 Under 24Under 2Ask a doctor
24-352-32
36-474-53
48-596-84
60-719-105
72-95116

*or as directed by a doctor

Other information

  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
  • avoid high humidity
  • protect from light
  • 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, ethylcellulose, FD&C blue #1 aluminum lake, 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®†

Rapid Tabs

NDC 59779-452-01 

Children's
Pain Relief
ACETAMINOPHEN, 80 mg

Pain reliever, Fever reducer
Ages 2-6

• Aspirin free
• Ibuprofen free

30 TABLETS

Grape 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      ORG101345201

Distributed by:
CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2015 CVS/pharmacy    CVS.com® 
1-800-SHOP CVS   V-11112

CVS 44-452

CVS 44-452

CHILDRENS PAIN RELIEF 
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-452
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN80 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
DEXTRATES (UNII: G263MI44RU)  
Product Characteristics
ColorPURPLEScoreno score
ShapeROUNDSize13mm
FlavorGRAPEImprint Code 44;452
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-452-011 in 1 CARTON12/06/200404/03/2020
130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/06/200404/03/2020
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(59779-452)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(59779-452)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(59779-452)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(59779-452)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(59779-452)

Revised: 9/2017
Document Id: bc2b7b17-94ad-4db7-8727-d1c4fbdbf19a
Set id: e616d9c8-6e0e-9d6e-bd7a-bf14cf6780ec
Version: 9
Effective Time: 20170926
 
CVS Pharmacy