acetaminophen

Western Family Foods Inc

Western Family Acetaminophen Extended-Release Tablets 650mg Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each caplet)
• Purpose
• 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
• acetaminophen Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

acetaminophen Uses

• •temporarily relieves minor aches and pains due to:
• •muscular aches
• •backache
• •headache
• •minor pain of arthritis
• •temporarily reduces fever

Warnings

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

• •more than 6 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.
• •if you are allergic to acetaminophen or any of the inactive ingredients in this product

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.

Overdose warning: 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 overdose warning)

take 2 caplets every 8 hours with water

swallow whole – do not crush, chew, split or dissolve

do not take more than 6 caplets in 24 hours

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

•

•

•

•

•

adults and children 12 years and over
children under 12 years

acetaminophen Other information

• •store at 20°-25°C (68°-77°F). Avoid excessive heat 40°C (104°F).
• •see end panel for lot number and expiration date

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

8 Hour

Acetaminophen

FOR UP TO 8 HOUR RELIEF OF MINOR MUSCLE ACHES & PAIN

HEADACHE/BACKACHE/MINOR PAIN OF ARTHRITIS

EXTENDED-RELEASE TABLETS 650 mg

PAIN RELIEVER / FEVER REDUCER

Gluten Free

COMPARE TO TYLENOL® 8 HR active ingredient

650 mg each

*Capsule-Shaped Tablets

acetaminophen Acetaminophen TABLET, FILM COATED, EXTENDED RELEASE Product Information Product Type Human otc drug label Item Code (Source) NDC:55312-217 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN ACETAMINOPHEN 650 mg Inactive Ingredients Ingredient Name Strength carnauba wax SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES MAGNESIUM STEARATE maltodextrin cellulose, microcrystalline POLYETHYLENE GLYCOLS polysorbate 80 POVIDONES STEARIC ACID titanium dioxide Product Characteristics Color Size Imprint Code Shape RED 19 mm L217 CAPSULE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 50 in 1 BOTTLE 2 NDC:55312-217-71 1 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075077 2005-11-30