Cabinet Pain Reliever & Fever Reducer Refill, Acetaminophen

Cabinet Pain Reliever & Fever Reducer Refill, Acetaminophen
SPL v1
SPL
SPL Set ID 2744f082-adfd-4dfc-a87d-ed8c0d84a447
Route
ORAL
Published
Effective Date 2025-09-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: S53 Shape: capsule Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-12

Description

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 500 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

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

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

Drug Facts

Other Information

• store between 20–25°C (68–77°F)

Package Labeling:

Inactive Ingredients

hypermellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions Or Comments?

908-242-6108

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.

Active Ingredient (in Each Caplet)

Acetaminophen 500 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

Directions • Do Not Take More Than Directed (see Overdose Warning)

adults & children 12 years & over • take 2 caplets every 6 hours while symptoms last • do not take more than 6 caplets in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor
children under 12 years ask a doctor


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

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

Do Not Use (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

Drug Facts

Other Information

• store between 20–25°C (68–77°F)

Package Labeling:

Inactive Ingredients (Inactive ingredients)

hypermellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

908-242-6108

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 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.

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

Acetaminophen 500 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

Directions • Do Not Take More Than Directed (see Overdose Warning) (Directions • do not take more than directed (see overdose warning))

adults & children 12 years & over • take 2 caplets every 6 hours while symptoms last • do not take more than 6 caplets in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor
children under 12 years ask a doctor


Advanced Ingredient Data


Raw Label Data

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