CARE ONE PAIN RELIEF EXTRA STRENGTH - acetaminophen capsule, coated 
American Sales Company

----------

American Sales Company Pain Relief Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

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. 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 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 use more than directed (see Liver warning)

adults and children 12 years and over	take 2 caplets every 6 hours as needed do not take more than 8 caplets in 24 hours
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) and may cause liver damage

Other information

• store at 20º-25ºC (68º-77ºF)

Inactive ingredients

hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the Active Ingredient in Tylenol®

Pain Relief

Extra Strength

Acetaminophen

Pain Reliever - Fever Reducer

See New Warnings Information

500 mg Each

CARE ONE PAIN RELIEF  EXTRA STRENGTH acetaminophen   capsule, coated

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 41520-917 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   POLYETHYLENE GLYCOL   POVIDONE   STEARIC ACID

Product Characteristics Color WHITE Score no score Shape CAPSULE Size 16mm Flavor Imprint Code L917 Contains

Packaging # NDC Package Description Multilevel Packaging 1 41520-917-71 1 BOTTLE In 1 CARTON contains a BOTTLE 1 50 TABLET In 1 BOTTLE This package is contained within the CARTON (41520-917-71) 2 41520-917-78 1 BOTTLE In 1 CARTON contains a BOTTLE 2 100 TABLET In 1 BOTTLE This package is contained within the CARTON (41520-917-78) 3 41520-917-76 1 BOTTLE In 1 CARTON contains a BOTTLE 3 120 TABLET In 1 BOTTLE This package is contained within the CARTON (41520-917-76) 4 41520-917-90 500 TABLET In 1 BOTTLE None 5 41520-917-82 2 BOTTLE In 1 CARTON contains a BOTTLE 5 100 TABLET In 1 BOTTLE This package is contained within the CARTON (41520-917-82)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	02/04/2011

Labeler - American Sales Company (809183973)

Registrant - L Perrigo Company (006013346)

Establishment
Name	Address	ID/FEI	Operations
Granules India Limited		918609236	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
L Perrigo Company		006013346	REPACK, RELABEL

Establishment
Name	Address	ID/FEI	Operations
Sixarp LLC, Praxis		016329513	REPACK

Revised: 02/2011American Sales Company