FDA Label for Acetaminophen

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 20^o to 25^oC (68^o to 77^oF). Avoid excessive heat 40^oC (104^oF).
• do not use if carton is opened or foil inner seal is broken
• USP Dissolution test is pending 

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? 
 1-855-274-4122

DISTRIBUTED BY: WALGREENS CO.
200 WILMOTRD., DEERFIELD, IL 60015

MADE IN INDIA

Code: TS/DRUGS/22/2009

Package Label-Principal Display Panel - 650 Mg (24 Tablet Container Label)

Walgreens
NDC 0363-9604-07
TO OPEN: PUSH DOWN, TURN CAP
8 Hour
Arthritis Pain
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
Extended-
release tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (250 Tablet Bottle) - acetaminophen fig1

Package Label-Principal Display Panel - 650 Mg (24 Tablets Container Carton)

Walgreens
COMPARE TO the active ingredient of
TYLENOL^® 8HR ARTHRITIS PAIN ^*See top panel
NDC 0363-9604-07
8 Hour
TO OPEN:
PUSH DOWN
TURN CAP
Arthritis Pain
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
actual size
24 Extended-
release tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (250 Tablets Container Carton) - acetaminophen fig2