EXTRA STRENGTH ACETAMINOPHEN- acetaminophen capsule 
Sam's West 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.

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Pain Reliever

Active ingredient (in each caplet)

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

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 of 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 damamge. 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

caster oil, hypromellose, povidone, sodium starch glycolate*, starch, stearic acid
*may contain this ingredient

PRODUCT PACKAGING

NDC 68196-175-14        pain reliever

SIMPLY RIGHTâ„¢
Health Care

extra strength
acetaminophen

acetaminophen caplets, 500 mg
pain reliever / fever reducer

Compare to Extra Strength Tylenol® active ingredient†

non-aspirin
relieves minor aches & pains

500 caplets

actual size

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

50844     REV1012A17514

Distributed by:
SAM'S West, Inc.
Bentonville, AR 72716

Simply Right 44-175

Simply Right 44-175

EXTRA STRENGTH ACETAMINOPHEN 
acetaminophen capsule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68196-175
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CASTOR OIL (UNII: D5340Y2I9G)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 44;175
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68196-175-13 250 in 1 BOTTLE, PLASTIC
2 NDC:68196-175-14 500 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 04/02/1993
Labeler - Sam's West Inc (051957769)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(68196-175)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(68196-175)

Revised: 2/2013
Document Id: 90e22583-e04a-47a1-81b5-58cd8e1f36bf
Set id: e222f50d-3895-4124-8d92-5c5f4178ce96
Version: 9
Effective Time: 20130226
 
Sam's West Inc