simply right acetaminophen

Sam's West Inc

Sam’s West, Inc. Extra Strength Acetaminophen Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each caplet)
• Purpose
• simply right acetaminophen Uses
• Warnings
  • 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
  • If pregnant or breast-feeding
  • Keep out of reach of children
• Directions
• simply right acetaminophen Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel - package
• Principal Display Panel – single label

FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

simply right acetaminophen Uses

• •temporarily relieves minor aches and pains due to:
• •the common cold
• •headache
• •backache
• •minor pain of arthritis
• •toothache
• •muscular aches
• •premenstrual and menstrual cramps
• •temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage may occur if you take

• •more than 4,000 mg of acetaminophen in 24 hours
• •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.
• •if you have ever had an allergic reaction to this product or any of its ingredients

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

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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 Liver warning)

take 2 caplets every 6 hours while symptoms last

do not take more than 6 caplets in 24 hours, unless directed by a doctor

do not use for more than 10 days unless directed by a doctor

•

•

•

adults and children 12 years and over
children under 12 years	ask a doctor

simply right acetaminophen Other information

• •store at 20-25°C (68-77°F)

Inactive ingredients

carnauba wax*, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

*may contain one or more of these ingredients

Questions or comments?

1-800-809-0469

Principal Display Panel - package

TWIN PACK

extra strength

acetaminophen

500 mg caplets

pain reliever/fever reducer

Compare to Extra Strength Tylenol® active ingredient

Contains no aspirin

Easy to swallow

For adults

1200 caplets

actual size

Principal Display Panel – single label

Pain reliever

extra strength

acetaminophen

500 mg caplets

pain reliever/fever reducer

Compare to Extra Strength Tylenol® active ingredient

Contains no aspirin

Easy to swallow

For adults

actual size

600 caplets

simply right acetaminophen Acetaminophen TABLET Product Information Product Type Human otc drug label Item Code (Source) NDC:68196-553 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength carnauba wax STARCH, CORN HYPROMELLOSES POLYETHYLENE GLYCOLS POVIDONES STEARIC ACID CROSCARMELLOSE SODIUM Product Characteristics Color Size Imprint Code Shape WHITE 16 mm L484 CAPSULE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68196-553-61 600 in 1 BOTTLE 2 NDC:68196-553-04 2 in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date part part343 2014-02-13