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Acetaminophen Extended-Release Tablets, USP Pain Reliever/Fever Reducer 8277725/0121


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

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

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

  • 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.

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

These could be signs of a serious condition.

  • 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

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

adultstake 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 ageask a doctor
  • do not take more than directed (see overdose warning)

Other information

  • store at 20° to 25°C (68° to 77°F). Avoid excessive heat 40°C (104°F).
  • FOR YOUR PROTECTION: Do not use if blister is torn or broken.
  • supplied as unit dose packages of 30 (5 x 6) NDC 68084-777-25

Inactive ingredients

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


Questions?

Contains No Aspirin

PACKAGING INFORMATION American Health Packaging unit dose blisters contain drug product from Ohm Laboratories Inc. as follows: (650 mg / 30 UD) NDC 68084-777-25 packaged from NDC 51660-333

Distributed by: American Health Packaging Columbus, OH 43217

8277725/0121

  • about the drug product, call Sun Pharmaceutical Industries, Inc. at 1-800-406-7984
  • about the packaging, call American Health Packaging at 1-800-707-4621