Active Ingredient
Acetaminophen 500 mg
Pain Reliefextra Strength
FDA Label NDC 69168-235
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 Reliefextra Strength (NDC 69168-235). 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, purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you, 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
Purpose
Pain reliever/fever reducer
Uses
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 takemore than 4000 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
■ if you are allergic to acetaminophen ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask A Doctor Before Use If You Have
liver disease
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
symptoms do not improve pain gets worse or lasts for more than 10 days ■ fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present ■ a rare
sensitivity reaction occurs You may report side effects to 1-888-952-0050
■ symptoms do not improve ■ pain gets worse or lasts for more than 10 days ■ fever gets worse or lasts for more than 3 days ■ new symptoms occur ■ redness or swelling is present ■ a rare sensitivity reaction occurs
If Pregnant Or Breast-Feeding
ask a health professional before use
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin.
If You Are Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do not exceed recommended dosage.
Directions
■ do not use more than directed (see overdose warning)
■ adults and children 12 years and over: take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours.
■ do not use more than 10 days unless directed by a doctor
■ children under 12 years: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Inactive Ingredients
corn starch, hydroxypropyl methylcellulose, polyethylene glycol, pregelatinized starch, stearic acid, titanium dioxide.
May contain povidone, and sodium starch glycolate.
Package/Label Principal Display Panel
Health A2Z® Compare to Tylenol® active ingredient*
See New Warnings Information
Extra Strength
PAIN RELIEF
500mg
Acetaminophen
Pain Reliever-Fever Reducer
CONTAINS NO ASPIRIN
50 Tablets
Health A2z 235 (Pain Relief 1)
Label 235 (Pain Relief 2)
* Please review the disclaimer below.
