Pain Relief Acetaminophen 325 Mg Tablet
FDA Label NDC 84324-046

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nuvicare Llc for the product Pain Relief Acetaminophen 325 Mg (NDC 84324-046). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, warnings, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

■ headache

■ muscular aches

■ backache

■ minor pain of arthritis

■ the common cold

■ toothache
■ premenstrual and menstrual cramps
■ temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if

■ adult takes more than 4,000 mg of acetaminophen in 24 hours

■ child takes more than 5 doses in 24 hours, which is the maximum daily amount

■ taken with other drugs containing acetaminophen

■ adult has 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 and children 12 years and 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

Other Information

■ Store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

hypromellose-5, hypromellose-15, magnesium stearate, microcrystalline cellulose, polyethylene glycol-400, polyvinyl pyrrolidone, pregelatinized starch, stearic acid powder, talc, titanium dioxide.

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