Your browser does not support JavaScript! JUNIOR STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET, CHEWABLE [VALUE MERCHANDISERS COMPANY, INC.]
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RxNorm Names

JUNIOR STRENGTH PAIN RELIEVER (acetaminophen) tablet, chewable
[VALUE MERCHANDISERS COMPANY, INC.]


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 160 mg

Purpose

Pain Reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
  • 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 warnings for adult use
  • find the right dose on chart below. 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 48 under 6 Ask a doctor
 48-59 6-8 2
 60-71 9-10 2 1/2
 72-95 11 3
 96 and over 12 4

Other information

  • 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, dextrose, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, stearic acid, sucralose

Questions or comments?

1-800-426-9391

Product Packaging

Best Choice® Brand
HEALTH CARE

Compare to the active ingredient in Junior Strength Tylenol® Meltaways®*

Grape Flavor

Jr. Strength

AGES 6-11

PAIN RELIEVER RAPID MELTS
contains Acetaminophen

Pain Reliever/Fever Reducer

Aspirin Free • Ibuprofen Free

24 Quick Melts -160 mg

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Junior Strength Tylenol® Meltaways®.
 50844       REV1012C44908

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

Best Choice 44-449

Best Choice 44-449

JUNIOR STRENGTH PAIN RELIEVER 
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63941-449
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
CROSPOVIDONE 
D&C RED NO. 27 
D&C RED NO. 30 
DEXTROSE 
ETHYLCELLULOSES 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
MANNITOL 
STEARIC ACID 
SUCRALOSE 
Product Characteristics
ColorPURPLEScoreno score
ShapeROUNDSize16mm
FlavorGRAPEImprint Code 44;449
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63941-449-081 in 1 CARTON
124 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/28/2005
Labeler - VALUE MERCHANDISERS COMPANY, INC. (868703513)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(63941-449)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(63941-449)

Revised: 7/2013
 
VALUE MERCHANDISERS COMPANY, INC.

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