FDA Label for Atamel Forte
View Indications, Usage & Precautions
Atamel Forte Product Label
The following document was submitted to the FDA by the labeler of this product Rapha Health Network International 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.
Active Ingredient (In Each Tablet)
Acetaminophen 500 mg *Nonsteroidal antiinflammatory drug
Purpose
Pain reliever/fever reducer aid
Uses:
• for the temporary relief of minor aches and pains as recommended by your doctor. Because of delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. • Muscular aches. • Ask your doctor for other uses for this product.
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 which is the maximum daily amount • 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.
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.
Ask A Doctor Before Use If
you have liver disease
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 • 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.
If Pregnant Or Breast-Feeding,
ask a health professional 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
Take with a full glass of water do not take more than directed Do not take more than 6 tablets in 24 hours
| Adults and children over 12 years of age | Take 2 tablets every 6 hours, not more than 6 tablets in 24 hours |
| Children under 12 years of age | Ask a doctor |
Other Information
• store at room temperature between 20°C - 25°C (68°F to 77°F)
• Read all information before using this product. Keep this box for important information
• DO NOT USE IF CARTON IS OPENED AND/OR SAFETY SEAL IS BROKEN OR MISSING
Inactive Ingredients
Colloidal silicon dioxide, sodium croscarmellose, magnesium stearate, corn starch, microcrystalline cellulose
Package Labeling:
* Please review the disclaimer below.
