FDA Label for Acetaminophen Extended-release Tablets, 650 Mg

Active Ingredient (In Each Caplet)

Acetaminophen 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 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.

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 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 age	ask a doctor

Other information

• store between 20-25°C (68-77°F)
• The FDA approved Dissolution methods differ from USP
• do not use if carton is opened. Do not use if foil inner seal is broken or missing

Inactive Ingredients

carnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin

Questions or comments ?
Call at 1-877-376-4271 Mon-Fri 9.00am - 6.00pm EST

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NDC 25000-071-02
Acetaminophen Extended-Release Tablets USP, 650 mg
24 count carton label

aceta-24s-carton - aceta 24s carton

NDC 25000-071-02
Acetaminophen Extended-Release Tablets USP, 650 mg
24 count bottle label

NDC 25000-071-08
Acetaminophen Extended-Release Tablets USP, 650 mg
100 count carton label

NDC 25000-071-08
Acetaminophen Extended-Release Tablets USP, 650 mg
100 count bottle label

NDC 25000-071-10
Acetaminophen Extended-Release Tablets USP, 650 mg
225 count carton label

NDC 25000-071-10
Acetaminophen Extended-Release Tablets USP, 650 mg
225 count bottle label

NDC 25000-071-11
Acetaminophen Extended-Release Tablets USP, 650 mg
290 count carton label

NDC 25000-071-11
Acetaminophen Extended-Release Tablets USP, 650 mg
290 count bottle label