Acetaminophen Extended-release Tablets Usp, 650 Mg

Acetaminophen Extended-release Tablets Usp, 650 Mg
SPL v7
SPL
SPL Set ID ed23c587-7806-1f64-e053-2a95a90aea7f
Route
ORAL
Published
Effective Date 2023-07-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg)
Inactive Ingredients
Povidone K30 Starch, Corn Sodium Starch Glycolate Type A Corn Polyethylene Glycol 400 Microcrystalline Cellulose Magnesium Stearate Hydroxyethyl Cellulose (140 Cps At 5%) Stearic Acid Hypromellose 2910 (6 Mpa.s)

Identifiers & Packaging

Pill Appearance
Imprint: G650 Shape: capsule Color: white Size: 19 mm Score: 1
Marketing Status
ANDA Active Since 2023-07-17

Description

Acetaminophen USP, 650 mg

Purpose

Pain reliever/ fever reducer


Medication Information

Purpose

Pain reliever/ fever reducer

Description

Acetaminophen USP, 650 mg

Pdp

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

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

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

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.

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

Other Information

■ store between 20-25°C (68-77°F)

■ do not use if foil inner seal is broken or missing

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.

Inactive Ingredients

hydroxy ethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions Or Comments?

contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

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.

Keep out of reach of children.

Active Ingredient (in Each Caplet)

Acetaminophen USP, 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

Pdp (PDP)

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

■ 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

Do Not Use (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

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.

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

Other Information

■ store between 20-25°C (68-77°F)

■ do not use if foil inner seal is broken or missing

Overdose Warning: (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.

Inactive Ingredients (Inactive ingredients)

hydroxy ethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions Or Comments? (Questions or comments?)

contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

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.)

Keep out of reach of children.

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

Acetaminophen USP, 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

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