CHILDRENS PAIN AND FEVER- acetaminophen tablet, chewable 
Walgreen Company

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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Walgreens 44-452

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

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

  • rash
  • skin reddening 
  • blisters

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

  • do not give more than directed 
  • 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
  • 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, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

Questions or comments?

1-800-426-9391

Principal Display Panel

Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDEDǂ

NDC 0363-0452-01

children's
FAST-DISSOLVING
Pain & Fever
Acetaminophen 80 mg / 
Pain Reliever / Fever Reducer
• Aspirin free  • Ibuprofen free
• Ages 2 to 6

30 FAST-DISSOLVING
TABLETS

GRAPE FLAVOR

Compare to Children's Tylenol® Meltaways® active ingredientǂǂ

ǂWalgreens Pharmacist Survey Study, November 2014.
ǂǂThis product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Tylenol® Meltaways®.

50844    REV0416B45201

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
Walgreens
100% SATISFACTION GUARANTEED
walgreens.com   ©2016 Walgreen Co.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSINGWalgreens 44-452

Walgreens 44-452

CHILDRENS PAIN AND FEVER 
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0452
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 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
CROSPOVIDONE (UNII: 2S7830E561)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
Product Characteristics
ColorPURPLEScoreno score
ShapeROUNDSize13mm
FlavorGRAPEImprint Code 44;452
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0452-011 in 1 CARTON12/06/200405/07/2021
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 FINALpart34312/06/200405/07/2021
Labeler - Walgreen Company (008965063)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(0363-0452)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(0363-0452)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(0363-0452)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(0363-0452)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(0363-0452)

Revised: 6/2018
Document Id: 2bbe2404-e489-43e5-b713-afd22f7778f0
Set id: 347fc07c-6bf3-4547-a93b-ae0e687a6364
Version: 6
Effective Time: 20180607
 
Walgreen Company