8hr Muscle Aches & Pain Relief

8hr Muscle Aches & Pain Relief
SPL v7
SPL
SPL Set ID ed25620f-e39b-e30c-e053-2995a90af621
Route
ORAL
Published
Effective Date 2023-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

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:

■ muscular aches

■ backache

■ minor pain of arthritis

■ toothache

■ premenstrual and menstrual cramps

■ headache

■ the common cold

■ temporarily reduces fever

Directions

do not take more than directed (see overdose warning)

adults and children ■ 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 12 years of age and over

children under 12 years ■ 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

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.

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.

Other Information

■ store between 20-25°C (68-77°F)

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

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:

■ muscular aches

■ backache

■ minor pain of arthritis

■ toothache

■ premenstrual and menstrual cramps

■ headache

■ the common cold

■ temporarily reduces fever

Purpose

Pain reliever/fever reducer

Directions

do not take more than directed (see overdose warning)

adults and children ■ 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 12 years of age and over

children under 12 years ■ do not use

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

Liver Warning (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: (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.

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.

Other Information (Other information)

■ store between 20-25°C (68-77°F)

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

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

All Sections (JSON)