The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Acetaminophen 500 mg
Otc - Active Ingredient
Acetaminophen 500 mg
Otc - Purpose
Pain reliever/fever reducer
Indications & Usage
•temporarily relieves minor aches and pains due to:
•the common cold
•minor pain of arthritis
•premenstrual and menstrual cramps
•temporarily reduces fever
WarningsLiver 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:
If a skin reaction occurs, stop use and seek medical help right away.
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
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.
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.Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right 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.
Dosage & Administration
- Directionsdo not take more than directed (see overdose warning)adults and children 12 years and overtake 2 caplets every 6 hours while symptoms lastdo not take more than 6 caplets in 24 hours, unless directed by a doctordo not use for more than 10 days unless directed by a doctorchildren under 12 yearsask a doctor
- Store between 20-25°C (68-77°F)
Inactive ingredients Croscarmelose Sodium,Crospovidone,FD&C red #40 aluminium lake, FD&C yellow # 6 alluminium lake,hypromelose,Magnesium Stearate, Mica based Pearlescent pigment, polyethylene glycol 400,polyethylene glycol 6000, polysorbate 80, povidone, pregelatinized starch.
Otc - Questions
* Please review the disclaimer below.