FDA Label for Acetaminophen
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- LIVER WARNING
- DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Acetaminophen Product Label
The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceuticals Llc. 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.
Other
Drug facts
Warnings
Distributed By
Spirit Pharmaceuticals, LLC
Ronkonkoma, NY 11779
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
Liver Warning
This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. 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 drugs every day while using this product
- Skin reddening
- Blisters
- Rash
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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
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 12 years
- 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.
Directions
do not take more than directed (see overdose warning)
adults and children 12 years and over |
|
children 6 years to under 12 years |
|
children under 6 years | ask a doctor |
Other Information
- store between 20-25°C (68-77°F)
- do not use if carton is opened or neck wrap or foil inner seal imprinted with "SAFETY SEAL®" is broken or missing
Inactive Ingredients
povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Questions Or Comments?
1-888-333-9792
Principal Display Panel
VALUMEDS™
Compare to the active ingredient in
Regular Strength Tylenol®*
REGULAR STRENGTH
PAIN RELIEF
ACETAMINOPHEN 325 mg
PAIN RELIVER/FEVER REDUCER
100 TABLETS
ACTUAL SIZE
* Please review the disclaimer below.