Acetaminophen 500 mg Caplet
SPL UNCLASSIFIED SECTION
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each caplet)
Acetaminophen 500 mg
OTC - PURPOSE SECTION
Purposes Pain reliever/fever reducer
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves minor aches and pains due to:
- headache
- muscular aches
- backache
- minor pain of arthritis
- the common cold
- toothache
- premenstrual and menstrual cramps
- temporarily reduces fever
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
- 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
OTC - DO NOT USE SECTION
Do not use
- with any other drug containing acetaminophen (prescription or non prescription). 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 SECTION
Ask a doctor before use if you have liver disease.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
OTC - STOP USE SECTION
Stop use and ask a doctor if
These could be signs of a serious condition.
- 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
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Overdose warning: In the 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 SECTION
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 6 caplets in 24 hours unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
- children under 12 years: ask a doctor
STORAGE AND HANDLING SECTION
Other information
- store at room temperature in a dry place
INACTIVE INGREDIENT SECTION
Inactive ingredients Povidone, pregelatinized starch, sodium starch glycolate, stearic acid
OTC - QUESTIONS SECTION
Questions? If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.
SPL UNCLASSIFIED SECTION
Distributed By: Plus Pharma, Commack, NY 11725
Manufactured in a GMP facility in the USA
HOW SUPPLIED
Product: 50090-5537
NDC: 50090-5537-1 100 TABLET in a BOTTLE, PLASTIC