Arthritis Pain Reliever: Package Insert and Label Information

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

Drug Facts

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
premenstrual and menstrual cramps
the common cold
headache
toothache
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

Allergy alert

acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

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)

adults

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 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 batch number and expiration date
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

Inactive ingredients

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

Questions?

call 1-800-406-7984

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901

PRINCIPAL DISPLAY PANEL — 650 mg CAPLET Bottle Carton

NDC 51660-333-50

Compare To the active ingredient of Tylenol® Arthritis Pain

Ohm®


Last up to 8 Hours

Use only as directed.

Arthritis Pain Relief
Acetaminophen
Extended-release Tablets USP, 650 mg
Pain Reliever/Fever Reducer

For the Temporary Relief of Minor Arthritis Pain

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

50 CAPLETS* (*Capsule-Shaped Tablets)

PDP-50
(click image for full-size original)

Package/Label Principal Display Panel

NDC 51660-333-01

Compare To the active ingredient of Tylenol® Arthritis Pain

Ohm®


Last up to 8 Hours

Use only as directed.

Arthritis Pain Relief
Acetaminophen
Extended-release Tablets USP, 650 mg
Pain Reliever/Fever Reducer

For the Temporary Relief of Minor Arthritis Pain

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

100 CAPLETS* (*Capsule-Shaped Tablets)

PDP-100
(click image for full-size original)

Principal Display Panel

NDC 51660-333-24

Compare To the active ingredient of Tylenol® Arthritis Pain

Ohm®


Last up to 8 Hours

Use only as directed.

Arthritis Pain Relief
Acetaminophen
Extended-release Tablets USP, 650 mg
Pain Reliever/Fever Reducer

For the Temporary Relief of Minor Arthritis Pain

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

24 CAPLETS* (*Capsule-Shaped Tablets)

PDP-24ct
(click image for full-size original)
PDP-24ct
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
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM LAURYL SULFATE
STEARIC ACID
TITANIUM DIOXIDE
STARCH, CORN
PROPYLENE GLYCOL
POVIDONE, UNSPECIFIED
CROSPOVIDONE
Product Characteristics
Color white Score no score
Shape OVAL Size 19mm
Flavor Imprint Code cor116
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51660-333-01 1 BOTTLE in 1 CARTON contains a BOTTLE
1 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE This package is contained within the CARTON (51660-333-01)
2 NDC:51660-333-50 1 BOTTLE in 1 CARTON contains a BOTTLE
2 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE This package is contained within the CARTON (51660-333-50)
3 NDC:51660-333-24 1 BOTTLE in 1 CARTON contains a BOTTLE
3 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE This package is contained within the CARTON (51660-333-24)
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)
Establishment
Name Address ID/FEI Operations
Ohm Laboratories Inc. 184769029 MANUFACTURE (51660-333)

Revised: 11/2021 Ohm Laboratories Inc.

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