ACETAMINOPHEN RAPID RELEASE EXTRA STRENGTH - acetaminophen tablet, coated 
Western Family Foods Inc

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Western Family Foods, Inc. Acetaminophen Gelcaps Drug Facts

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
• headache
• muscular aches
• backache
• minor pain of arthritis
• the common cold
• toothache
• 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 gelcaps 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

• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days

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. 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 use more than directed (see Liver warning)

adults and children 12 years and over	take 2 gelcaps every 6 hours while symptoms last do not take more than 8 gelcaps in 24 hours do not use for more than 10 days unless directed by a doctor
children under 12 years	do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and could cause liver damage

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #33, edible ink, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, polyethylene glycol, povidone, starch, stearic acid, titanium dioxide

Principal Display Panel

See New Warnings Information

Extra Strength

Rapid Release

Acetaminophen

Pain Reliever/Fever Reducer

Fast Relief

Compare to Tylenol® Rapid Release Gels active ingredient

500 mg each

ACETAMINOPHEN  RAPID RELEASE EXTRA STRENGTH acetaminophen   tablet, coated

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 55312-046 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 No Inactive Ingredients Found

Product Characteristics Color RED (grey top) Score no score Shape CAPSULE (tablet) Size 19mm Flavor Imprint Code L046 Contains

Packaging # NDC Package Description Multilevel Packaging 1 55312-046-71 1 BOTTLE In 1 CARTON contains a BOTTLE 1 50 TABLET In 1 BOTTLE This package is contained within the CARTON (55312-046-71) 2 55312-046-78 1 BOTTLE In 1 CARTON contains a BOTTLE 2 100 TABLET In 1 BOTTLE This package is contained within the CARTON (55312-046-78)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	08/19/2009

Labeler - Western Family Foods Inc (192166072)

Revised: 06/2009Western Family Foods Inc