Regular Strength Pain Reliever
Drug Facts
Active Ingredient (in each tablet)
Acetaminophen 325 mg
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 4,000 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.
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 the user has liver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin
OTC - STOP USE SECTION
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 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.
OVERDOSAGE SECTION
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.
Directions
do not take more than directed (see overdose warning)
| adults & children 12 years & over | • take 2 tablets every 4 to 6 hours while symptoms last • do not take more than 10 tablets in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor |
| children 6 years to under 12 years | • take 1 tablet every 4 to 6 hours while symptoms last • do not take more than 5 tablets in 24 hours • do not use for more than 5 days unless directed by a doctor |
| children under 6 years | ask a doctor |
Other information
• store between 20–25°C (68–77°F)
Inactive ingredients
croscarmellose sodium, povidone, pregelatinized starch, stearic acid
SPL UNCLASSIFIED SECTION
Distributed By: Spirit Pharmaceuticals, LLCRonkonkoma, NY 11779