Pain Reliever

Pain Reliever
SPL v6
SPL
SPL Set ID bdb09e15-8e17-4987-99d0-bab8856a2109
Route
ORAL
Published
Effective Date 2022-07-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg)
Inactive Ingredients
Hypromelloses Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Pyrrolidone Starch, Corn Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: S99 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-19

Description

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 325 mg

Uses

• temporarily relieves minor aches and pains due to: • the common cold • headache • backache • minor pain of arthritis • toothache • muscular aches • premenstrual and menstrual cramps • temporarily reduces fever

Section 34088-5

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.

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.

Section 50568-5

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if the user has liver disease

Section 50570-1

Do not use • with any other drug containing acetaminophen (prescription or non prescription). 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

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 4,000 mg of acetaminophen in 24 hours • 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.

Directions

do not take more than directed (see overdose warning)

adults & children 12 years & over • take 2 tablets every 4 to 6 hours while symptoms last

• do not take more than 10 tablets in 24 hours, unless directed by a doctor

• do not use for more than 10 days unless directed by a doctor
children 6 years to under 12 years • take 1 tablet every 4 to 6 hours while symptoms last

• do not take more than 5 tablets in 24 hours

• do not use for more than 5 days unless directed by a doctor
children under 6 years ask a doctor

Drug Facts

Other Information

• store between 20–25°C (68–77°F)

Inactive Ingredients

hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl pyrrolidone, pre-gelatinized starch, stearic acid, talc, titanium dioxide

Questions Or Comments?

1-888-333-9792

Principal Display Panel

Label

Caton

Active Ingredient (in Each Tablet)

Acetaminophen 325 mg


Structured Label Content

Uses

• temporarily relieves minor aches and pains due to: • the common cold • headache • backache • minor pain of arthritis • toothache • muscular aches • premenstrual and menstrual cramps • temporarily reduces fever

Section 34088-5 (34088-5)

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.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if the user has liver disease

Section 50570-1 (50570-1)

Do not use • with any other drug containing acetaminophen (prescription or non prescription). 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

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Pain reliever/fever reducer

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 4,000 mg of acetaminophen in 24 hours • 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.

Directions

do not take more than directed (see overdose warning)

adults & children 12 years & over • take 2 tablets every 4 to 6 hours while symptoms last

• do not take more than 10 tablets in 24 hours, unless directed by a doctor

• do not use for more than 10 days unless directed by a doctor
children 6 years to under 12 years • take 1 tablet every 4 to 6 hours while symptoms last

• do not take more than 5 tablets in 24 hours

• do not use for more than 5 days unless directed by a doctor
children under 6 years ask a doctor

Drug Facts

Other Information (Other information)

• store between 20–25°C (68–77°F)

Inactive Ingredients (Inactive ingredients)

hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl pyrrolidone, pre-gelatinized starch, stearic acid, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Principal Display Panel

Label

Caton

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Acetaminophen 325 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)