PAIN RELIEF JUNIOR STRENGTH- acetaminophen tablet, chewable 
Meijer Distribution Inc

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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Meijer 44-449-Discontinued

Active ingredient (in each tablet)

Acetaminophen 160 mg

Purpose

Pain Reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • sore throat
    • flu
    • toothache
    • the common cold
  • 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 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) Dose (Tablets)*
 Under 48 Under 6 Ask a doctor
 48-59 6-8 2
 60-71 9-10 2 1/2
 72-95 11 3

 * or as directed by a doctor

Other information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • 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

NDC 41250-449-08

Compare to Jr. Tylenol® Meltaways® active ingredient†

meijer

For Ages 6 to 11
Junior
PainRelief
Acetaminophen
 • Pain Reliever/Fever Reducer

Rapid Melts • Grape Flavor

Chewable

24 Tablets-160 mg Each

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Jr. Tylenol® Meltaways®.     50844      REV0416A44908

DIST. BY MEIJER
DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
www.meijer.com

Meijer 44-449

Meijer 44-449

PAIN RELIEF  JUNIOR STRENGTH
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-449
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
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)  
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorPURPLEScoreno score
ShapeROUNDSize16mm
FlavorGRAPEImprint Code 44;449
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41250-449-084 in 1 CARTON01/28/200504/18/2019
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/28/200504/18/2019
Labeler - Meijer Distribution Inc (006959555)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(41250-449)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(41250-449)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(41250-449)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(41250-449)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(41250-449)

Revised: 10/2018
 
Meijer Distribution Inc