Pain Relief Tablet
FDA Label NDC 69168-005

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Pain Relief (NDC 69168-005). 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(s), purpose, use(s), warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient(s)

→ Purpose

→ Use(s)

→ Warnings

→ Do Not Use

→ Ask A Doctor Before Use If

→ Ask A Doctor Or Pharmacist Before Use If

→ Stop Use And Ask A Doctor If

→ Pregnancy/breastfeeding

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel

Active Ingredient(S)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Use(S)

temporary relief of minor aches and pains associated with ■ common cold ■ headache ■ toothache

■ muscular aches ■ backache ■ arthritis ■ menstrual cramps ■ and reduction of fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4000 mg of acetaminophen 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

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

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

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

Pregnancy/Breastfeeding

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

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center right away.
Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.