acetaminophen extended-release tablets

acetaminophen extended-release tablets
SPL v4
SPL
SPL Set ID 9d22bedb-9fc9-8421-e053-2a95a90acf4a
Route
oral
Published
Effective Date 2020-01-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (650 mg)
Inactive Ingredients
hydroxyethyl cellulose, unspecified hypromellose, unspecified magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified povidone stearic acid

Identifiers & Packaging

Pill Appearance
Imprint: G650 Shape: capsule Color: white Size: 20 mm Score: 1
Marketing Status
anda completed Since 2020-01-24 Until 2020-01-29
Purpose

Pain reliever/fever reducer

Description

Acetaminophen 650 mg

Medication Information

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.
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
Purpose

Pain reliever/fever reducer

Directions
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 20º to 25ºC (68º to 77º F)
Inactive Ingredients

hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

Description

Acetaminophen 650 mg

Questions?

call toll-free 1-800-935-6737

Do Not Use
  • with any other drugs 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
Package Labeling:

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 (1-800-222-1222) right away. Quick medical  attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each caplet)

Acetaminophen 650 mg

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

Structured Label Content

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.
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
Purpose

Pain reliever/fever reducer

Directions
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 (Other information)
  • store between 20º to 25ºC (68º to 77º F)
Inactive Ingredients (Inactive ingredients)

hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

Questions?

call toll-free 1-800-935-6737

Do Not Use (Do not use)
  • with any other drugs 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
Package Labeling:

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical  attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each caplet) (Active ingredient (in each caplet))

Acetaminophen 650 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:47.049533 · Updated: 2026-03-14T22:59:54.471917