Drug Facts

Active ingredient (in each extended-release tablet)

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 tablets 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 tablets every 8 hours with water
• swallow whole; do not crush, chew, split or dissolve
• do not take more than 6 tablets 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 20o to 25oC (68o to 77oF). Avoid excessive heat 40oC (104oF). 
• do not use if carton is opened or foil inner seal is broken
• Meets USP dissolution test 3

Inactive ingredients

colloidal silicon dioxide, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide, triacetin

Questions or comments? 
 call 1-855-274-4122

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road,
East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (225 Tablets Bottle)

AUROHEALTH
TO OPEN: 1. PUSH DOWN         NDC 58602-730-28
                   2. TURN CAP
DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN
8 HOUR    ARTHRITIS PAIN
Acetaminophen
Extended-Release
Tablets USP
650 mg
Pain Reliever/Fever Reducer
For the Temporary Relief of
Minor Arthritis Pain
225 Extended-release tablets

          

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (225 Tablets Container Carton)

AUROHEALTH
NDC 58602-730-28
*Compare to the Active
Ingredient in Tylenol®
8 HR Arthritis Pain
DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN
8 HOUR ARTHRITIS PAIN
Acetaminophen
Extended-Release
Tablets USP
650 mg
Pain Reliever/Fever Reducer
For the Temporary Relief of
Minor Arthritis Pain
225 Extended-release tablets