Active Ingredient(S)
Acetaminophen 500mg
Pain Relief Capsule, Coated
FDA Label NDC 69168-426
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 69168-426). 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
Purpose
Pain reliever/fever reducer
Use(S)
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 4,000mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash If a skin reaction occurs, stop use and seek medical help right away.
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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 - You may report side effects to 1-888-952-0050
Pregnancy/Breastfeeding
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 (1-800-222-1222) right away.
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 and children 12 years and over:
- take 2 caplets every 6 hours while symptoms last
- do not take more than 8 caplets in 24 hours, unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
- Ask a doctor
Children under 12 years:
Other Information
do not use if imprinted safety seal under cap is broken or missing
Storage
store between 20°-25°C (68°-77°F)
Inactive Ingredients
corn starch*, hypromellose, polyethylene glycol, povidone, pregelatinized starch,
purified water*, sodium starch glycolate, stearic acid, titanium dioxide*
*may contain these ingredients
Questions
Call 1-888-952-0050 Monday to Friday 9am-5pm EST
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Acetaminophen (426 328 012 Acetaminophen 500mg 1)
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