APAP ARTHITIS - acetaminophen tablet, film coated, extended release
Physicians Total Care, Inc.

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Amerisource Bergen Pain Relief Drug Facts

Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:
arthritis
the common cold
headache
toothache
muscular aches
backache
menstrual cramps
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

if you are allergic to acetaminophen
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 for more than 10 days
fever gets worse or lasts for 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: Taking more than the recommended dose (overdose) may cause liver damage. 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)

adults	take 2 caplets every 8 hours with water swallow whole – do not crush, chew or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor
under 18 years of age	ask a doctor

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, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Tylenol® Arthritis Pain active ingredient

See New Warnings Information

For the temporary relief of minor arthritis pain

ASPIRIN FREE

Pain Relief

acetaminophen extended-release tablets, 650 mg

pain reliever/fever reducer

Arthritis Pain

650 mg each

*Capsule-Shaped Tablets

NDC 54868*-2801-0

APAP ARTHITIS
acetaminophen tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:54868-2801(NDC:24385-629)
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	650 mg

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
POVIDONE
STEARIC ACID
TITANIUM DIOXIDE

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE (caplet)	Size	19mm
Flavor		Imprint Code	L544
Contains

#	Item Code	Package Description
Packaging
1	NDC:54868-2801-0	1 in 1 CARTON
1		100 in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA075077	10/29/2010	01/24/2014

Labeler - Physicians Total Care, Inc. (194123980)

Name	Address	ID/FEI	Business Operations
Establishment
Physicians Total Care, Inc.		194123980	relabel(54868-2801)

Revised: 1/2014

Document Id: bce0eae3-70df-43d8-8a1a-7b150dde95f5

Set id: 3d15a67f-963a-45fd-bf25-7762452f2dbd

Version: 2

Effective Time: 20140124

Physicians Total Care, Inc.