Acetaminophen: Package Insert and Label Information

ACETAMINOPHEN- acetaminophen tablet, extended release
Ohm Laboratories Inc.

ACTIVE INGREDIENT (IN EACH GELTAB)

Acetaminophen USP, 650 mg

PURPOSE

Pain reliever/fever reducer

USES

  • temporarily relieves minor aches and pains due to:
    • muscular aches
    • backache
    • headache
    • toothache
    • the common cold
    • minor pain of arthritis
    • premenstrual and menstrual cramps
  • temporarily reduces fever

WARNINGS

Liver warning: This product contains acetaminophen. Sever liver damage may occur if you take

  • more than 6 geltabs 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 have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets.
  • 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
  • the tablet got stuck in your throat

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 geltabs every 8 hours. Swallow only one geltab at a time.
    ▪ take a sip of water before swallowing each geltab and wash each geltab down with water (up to a full 8 oz. glass).
    ▪ swallow whole — do not crush, chew, split or dissolve
    ▪ do not take more than 6 geltabs 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 high humidity.
  • 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

Croscarmellose sodium, gelatin, glycerin, hypromellose, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, starch, titanium dioxide

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient of Tylenol® Arthritis Pain

NDC 51660-340-20

ohm ®

Use only as directed.

Arthritis Pain Relief

ACETAMINOPHEN

Extended-Release Tablets, USP 650 mg

Pain Reliever/Fever Reducer

Lasts up to 8 hrs

For the Temporary Relief of Minor Arthritis Pain

20 GELTABS * 650 mg EACH

(* Gelatin-Coated Tablets)

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

Distributed by: Ohm Laboratories Inc.

5101798/0313

20's bottle carton label
(click image for full-size original)
ACETAMINOPHEN
acetaminophen tablet, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51660-340
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
GELATIN
GLYCERIN
HYPROMELLOSES
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
POVIDONE
STARCH, CORN
PROPYLENE GLYCOL
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
Product Characteristics
Color white (White to Yellow) Score no score
Shape ROUND Size 13mm
Flavor Imprint Code 350
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51660-340-20 1 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 20 TABLET, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (51660-340-20)
2 NDC:51660-340-08 80 TABLET, EXTENDED RELEASE (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078569 12/21/2012
Labeler — Ohm Laboratories Inc. (184769029)
Registrant — Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Operations
Ohm Laboratories Inc. 184769029 manufacture (51660-340)

Revised: 04/2013 Ohm Laboratories Inc.

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