Active Ingredient (In Each Gelcap)
Acetaminophen, USP 500 mg
Acetaminophen Tablet
FDA Label NDC 0363-9798
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Co. for the product Acetaminophen (NDC 0363-9798). 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 gelcap), purpose, uses, liver warning, allergy alert, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, 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
■ temporarily relieves minor aches and pains due to:
■ headache
■ muscular aches
■ backache
■ minor pain of arthritis
■ toothache
■ he common cold
■ premenstrual and menstrual cramps
■ temporarily reduces fever
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 nonprescription). If you are not sure
whether a drug contains acetaminophen, ask a doctor or pharmacist
■ if you have ever had an allergic reaction to this product or any of its ingredients
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.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of The Reach Of Children.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222)
right away. Prompt medical attention is critical for adults as well as for children even if you do not
notice any signs or symptoms.
Overdose Warning
In case of accidental overdose, get medical help or contact a Poison Control Centerright 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 and children 12 years and over
■ take 2 gelcaps every 6 hours while symptoms last
■ do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
■ do not take more than 10 days unless directed by a doctor
children under 12 years
■ ask a doctor
Other Information
- store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature
■ avoid high humidity
■ see end panel for lot number and expiration date
Inactive Ingredients
ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hypromellose, iron oxide red, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, yellow iron Oxide.
Questions Or Comments ?
call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.
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