ARTHRITIS PAIN RELIEVER - acetaminophen tablet, film coated, extended release
Ohm Laboratories Inc.

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ACTIVE INGREDIENT (IN EACH CAPLET)

Acetaminophen USP, 650 mg

PURPOSE

Pain reliever/fever reducer

USES

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

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.
if you have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets.

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

the tablet got stuck in your throat
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: 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
children 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 batch number and expiration date
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN. (for non CRC packages)

INACTIVE INGREDIENTS

croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

QUESTIONS?

call 1-800-406-7984

Contains No Aspirin

Keep the carton. It contains important information.

Distributed by:

Ohm Laboratories Inc.

1385 Livingston Avenue

North Brunswick, NJ 08902

PRINCIPAL DISPLAY PANEL

ohm®

NDC 51660-333-50

Use only as directed.

Lasts up to 8 hours

Arthritis Pain Relief

Acetaminophen

Extended-Release Tablets, USP

Pain Reliever/Fever Reducer

For the Temporary Relief of Minor Arthritis Pain

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

50 CAPLETS*

650 mg EACH

(*capsule-shaped tablets)

†Compare to the active ingredient of Tylenol®Arthritis Pain

†This product is not manufactured or distributed by McNeil Consumer Healthcare, Inc., owner of the registered trademark Tylenol®Arthritis Pain.

This is the 50 count bottle carton label for Acetaminophen extended-release tablets, USP.

This is the 50 count bottle label for Acetaminophen extended-release tablets, USP.

ARTHRITIS PAIN RELIEVER
acetaminophen tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51660-333
Route of Administration	ORAL	DEA Schedule

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

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, PREGELATINIZED CORN
PROPYLENE GLYCOL
SODIUM LAURYL SULFATE
STEARIC ACID
TITANIUM DIOXIDE

Product Characteristics
Color	white	Score	no score
Shape	OVAL (Capsule Shaped)	Size	19mm
Flavor		Imprint Code	cor116
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:51660-333-50	50 TABLET, FILM COATED, EXTENDED RELEASE ( TABLET) in 1 BOTTLE	None
2	NDC:51660-333-01	100 TABLET, FILM COATED, EXTENDED RELEASE ( TABLET) in 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076200	04/30/2002

Labeler - Ohm Laboratories Inc. (184769029)

Registrant - Ohm Laboratories Inc. (051565745)

Establishment
Name	Address	ID/FEI	Operations
Ohm Laboratories Inc.		184769029	manufacture

Revised: 05/2012 Ohm Laboratories Inc.