Pain Reliever And Fever Reducer
FDA Label NDC 68210-4235

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Pain Reliever And Fever Reducer (NDC 68210-4235). 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 drug facts, active ingredient (in each tablet), purpose, uses, warning, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient (In Each Tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

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

Warning

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

Ask A Doctor Before Use If You Have

liver disease

Ask A Doctor Or Pharmacist Before Use If You Are If You Are

taking the blood thinning drug warfarin

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.

Directions

do not take more than directed (see overdose warning)

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

Other Information

• store between 20–25°C (68–77°F)

Inactive Ingredients

Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl pyrrolidone, pregelatinized starch, stearic acid, talc, titanium dioxide

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Distributed By:

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