ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet, coated 
Sam's West Inc

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Members Mark 44-519

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

  • if you are allergic to acetaminophen or any of the inactive ingredients in this product
  • 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
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • 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.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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, stearic acid, titanium dioxide

Principal Display Panel

Compare to Extra Strength Tylenol®
Rapid Release Gels 
active ingredient*

NDC 68196-919-05

Member's Mark®
QUALITY GUARANTEED

extra strength

acetaminophen
pain reliever/fever reducer
gelcaps, 500 mg

• non-aspirin
• relieves minor aches & pains

actual size

400
Gelcaps

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

*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the registered
trademark Extra Strength Tylenol® Rapid Release Gels.
50844      REV0322B51905

DISTRIBUTED BY: SAM'S WEST, INC., BENTONVILLE, AR 72716

100% MONEY BACK GUARANTEE
SUPERIOR QUALITY AND PERFORMANCE

We would like to hear from you with any comments or suggestions.
In the continental U.S. or Canada, you can call us at 1-800-426-9391
from 8:30 a.m to 4:00 p.m. EST Monday-Friday.

Members Mark 44-519

Members Mark 44-519

ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-919
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorred, blueScoreno score
ShapeOVALSize19mm
FlavorImprint Code L;5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68196-919-05400 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/10/2004
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01305/10/2004
Labeler - Sam's West Inc (051957769)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464manufacture(68196-919) , pack(68196-919)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(68196-919)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(68196-919)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088manufacture(68196-919)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(68196-919)

Revised: 10/2023
Document Id: 55a567c1-640e-45fb-93f5-fefd2a2e59ae
Set id: dd99efd0-4ca4-4dc6-a940-bebd17ac8f8d
Version: 11
Effective Time: 20231021
 
Sam's West Inc