FDA Label for Acetaminophen
View Indications, Usage & Precautions
- DRUG FACTS
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS • LIVER WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF THE USER HAS
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE USER IS
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF THE REACH OF CHILDREN.
- OVERDOSE WARNING:
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- ACETAMINOPHEN 100 TABLET
Acetaminophen Product Label
The following document was submitted to the FDA by the labeler of this product Southern Sales & Service, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active Ingredient (In Each Tablet)
Acetaminophen 325 mg
Purpose
Pain reliever/fever reducer
Uses
for the temporary relief of minor aches and pains due to:
Headache
Muscular aches
Backache
Toothache
Premenstrual and menstrual cramps
Temporally reduces fever.
Warnings • Liver Warning
this product contains Acetaminophen. Severe liver damage may occur if
- adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
- child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
Do Not Use
- with any other drug containing acetaminophen (prescription or nonprescription)
- 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
Ask A Doctor Before Use If The User Has
liver disease
Ask A Doctor Or Pharmacist Before Use If The User Is
taking the blood thinning drug warfarin
Stop Use And Ask A Doctor If
Pain gets worse or lasts more than 10 days in adults.
Pain gets worse or lasts more than 5 days in children under under 12 years
Fever gets worse or last more than 3 days
new symptoms occur
Redness or swelling is present. These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a doctor before use.
Keep Out Of The Reach Of Children.
Overdose Warning:
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or syptoms.
- Do not take more tahn directed (see overdose warning)
Directions
Adults and Children 12 years and older | Take 2 tablets every 4 to 6 hours while symptoms last Do not take more than 12 tablets in 24 hours |
Children 6 to 11 years | Take 1 tablet every 4 to 6 hours while symptoms last Do not take more than 5 tablets in 24 hours |
Children under 6 years | Do not use regular Strength products in children uder 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage. |
Other Information
store at room temperature 20°-25°C (68-77°F)
Inactive Ingredients
Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid
* Please review the disclaimer below.