EXTRA STRENGTH NON-ASPIRIN- acetaminophen capsule, liquid filled 
CHAIN DRUG MARKETING ASSOCIATION 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.

----------

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.

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

QC

QUALITY

CHOICE®

NDC 63868-987-10

See New Warnings Information

Compare to the active Ingredient In Extra Strength Tylenol® Rapid Release Gels†

EXTRA STRENGTH

NON-ASPIRIN

PAIN RELIEF GELCAPS

Acetaminophen

Pain Reliever

Fever Reducer

100 GELCAPS, 500 mg EACH

Rapid Release

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 Extra Strength Tylenol® Rapid Release Gels.

50844        ORG070951912

©DISTRIBUTED BY QUALITY CHOICE

NOVI, MI 48376-0995

QC 95610

Product Packaging

Product Packaging

EXTRA STRENGTH NON-ASPIRIN 
acetaminophen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-987
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
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 GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code 44;519
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-987-101 in 1 CARTON
1100 in 1 BOTTLE, PLASTIC
2NDC:63868-987-501 in 1 CARTON
250 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/10/2004
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)

Revised: 07/2012
 
CHAIN DRUG MARKETING ASSOCIATION INC