Active Ingredient (In Each Tablet)
Acetaminophen 500mg
Acetaminophen
FDA Label NDC 73659-013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rapid Care, Inc for the product Acetaminophen (NDC 73659-013). 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 tablet), otc - purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Pain reliever/fever reducer
Uses
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:
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.
Otc - Do Not Use
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether drug contains acetaminophen, ask a doctor or pharmacist.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
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
- 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
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.
Dosage & Administration
Directions
do not take more than directed (see overdose warning)
Adults and children 12 years and over
- take 2 tablets every 6 hours while symptoms last
- do not take more than 8 tablets 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 of age
Other Information
store between 20°-25°C (68°-77°F)
Inactive Ingredient
corn starch, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide
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