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

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Quality Choice 44-519

Active ingredient

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

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

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

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

Other information

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.

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

50844        ORG070951912

©DISTRIBUTED BY QUALITY CHOICE

NOVI, MI 48376-0995

QC 95610

www.qualitychoice.com

Product Packaging

Product Packaging


EXTRA STRENGTH NON-ASPIRIN 
acetaminophen   capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)63868-519
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 GLYCOL 
POVIDONE 
PROPYLENE GLYCOL 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScore no score
ShapeCAPSULESize19mm
FlavorImprint Code 44;519
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
163868-519-121 BOTTLE In 1 CARTONcontains a BOTTLE, PLASTIC
1100 CAPSULE In 1 BOTTLE, PLASTICThis package is contained within the CARTON (63868-519-12)
263868-519-151 BOTTLE In 1 CARTONcontains a BOTTLE, PLASTIC
250 CAPSULE In 1 BOTTLE, PLASTICThis package is contained within the CARTON (63868-519-15)

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: 05/2011CHAIN DRUG MARKETING ASSOCIATION INC