DrugCite

EXTRA STRENGTH NON-ASPIRIN - acetaminophen capsule, liquid filled 
VALUE MERCHANDISERS COMPANY, INC.

Best Choice 44-519

Active ingredient

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
  • headache
  • the common cold
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

Liver warning:  This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 8 gelcaps in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks ever day while using this product

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.

Ask a doctor before use if you have

  • liver disease

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 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.

If pregnant or breast-feeding,

ask a health professional before use. Keep out of reach of children.

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 for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • adults and children 12 years and over
  • take 2 gelcaps every 4 to 6 hours while symptoms last
  • do not take more than 8 gelcaps in 24 hours
  • do not take for more than 10 days unless directed by a doctor
  • children under 12 years: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage

Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)
  • use by expiration date on package

Inactive ingredients

croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxide

Product Packaging

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

Best Choice®

HEALTH CARE

SEE NEW WARNINGS INFORMATION

COMPARE TO THE ACTIVE INGREDIENT IN EXTRA

STRENGTH TYLENOL® RAPID RELEASE GELS†

EXTRA STRENGTH

NON-ASPIRIN

ACETAMINOPHEN

PAIN RELIEVER/FEVER REDUCER

RAPID RELEASE

100 GELCAPS - 500 mg EACH

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

50844     REV0709A51912

PROUDLY DISTRIBUTED BY:

VALU MERCHANDISERS, CO.

KANSAS CITY, MO. 64111

Product Packaging

Product Packaging


EXTRA STRENGTH NON-ASPIRIN 
acetaminophen  capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 63941-519
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM  
D&C RED NO. 33  
FD&C BLUE NO. 1  
FD&C RED NO. 40  
GELATIN  
HYDROXYPROPYL CELLULOSE  
HYPROMELLOSES  
FERROSOFERRIC OXIDE  
FERRIC OXIDE YELLOW  
POLYETHYLENE GLYCOL  
POVIDONE  
PROPYLENE GLYCOL  
STEARIC ACID  
TITANIUM DIOXIDE  
Product Characteristics
Color RED Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 44;519
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 63941-519-12 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC
1 100 CAPSULE In 1 BOTTLE, PLASTIC This package is contained within the CARTON (63941-519-12)
2 63941-519-15 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC
2 50 CAPSULE In 1 BOTTLE, PLASTIC This package is contained within the CARTON (63941-519-15)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 05/10/2004

Labeler - VALUE MERCHANDISERS COMPANY, INC. (868703513)
Revised: 05/2011VALUE MERCHANDISERS COMPANY, INC.