DrugCite

EXTRA STRENGTH ACETAMINOPHEN - acetaminophen capsule 
Sam's West Inc

Pain Reliever

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • backache
    • toothache
    • the common cold
    • minor pain of arthritis
    • 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 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every 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 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

  • do not take more than directed (see overdose warning)
  • adults and children 12 years and over
    • take 2 caplets every 4 to 6 hours while symptoms last
    • do not take more than 8 caplets 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)
  • see end flap for expiration date and lot number

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 RIGHT
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 NDC Product Code (Source) 68196-175
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
HYPROMELLOSES  
STEARIC ACID  
CASTOR OIL  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 44;175
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 68196-175-13 250 CAPSULE In 1 BOTTLE, PLASTIC None
2 68196-175-14 500 CAPSULE In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 04/02/2023

Labeler - Sam's West Inc (051957769)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 MANUFACTURE
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 PACK
Revised: 02/2013Sam's West Inc