Otc - Active Ingredient
Active ingredient (in each caplet)
Acetaminophen 500 mg
Acetaminophen Tablet, Coated
FDA Label NDC 49035-869
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores Inc for the product Acetaminophen (NDC 49035-869). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Pain reliever/fever reducer
Indications & Usage
Uses
temporarily relieves minor aches and pains due to:
- headache
- the common cold
- backache
- minor pain of arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
temporarily reduces fever
Warnings
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 caplets in 4 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Otc - Ask Doctor
Ask a doctor before use if you have liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Otc - Stop Use
Stop use and ask a doctor if
- symptoms do not improve
- new symptoms occur
- pain or fever persists or gets worse
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Dosage & Administration
Directions
do not take more than directed.
adults and children 12 years and over:
take 2 caplets (1,000 mg) every 6 hours while symptoms last
do not take more than 6 caplets (3,000 mg) in 24 hours, unless directed by a doctor
do not use more than 10 days unless directed by a doctor
children under 12 years:ask a doctor
Storage And Handling
Other information
- SODIUM FREE
- store at 25°C (77°F) excursions permitted between 15-30°C (59-86°F)
- use by expiration date on package
Inactive Ingredient
Inactive ingredients
hypromellose, mineral oil, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid, titanium dioxide
*may contain this ingredient
Otc - Do Not Use
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
- for more than 10 days for pain unless directed by a doctor
- for more than 3 days for fever unless directed by a doctor
Package Label.Principal Display Panel
341r-walmart-500s-label (341r Walmart 500s Label)
* Please review the disclaimer below.
