Acetaminophen

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (IN EACH GELTAB)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen USP, 650 mg

PURPOSE

OTC - PURPOSE SECTION

Pain reliever/fever reducer

USES

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

• 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

OTC - ASK DOCTOR SECTION

Liver disease.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

Taking the blood thinning drug warfarin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

• 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

SPL UNCLASSIFIED SECTION

• 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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

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DailyMed Socrata Ingredients#

Products#

Every source-derived product name is available through these pages.

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• Acetaminophen
• 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

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