FDA Label for Adwe Feverx Acetaminophen Caplets, 500 Mg Extra Strength
View Indications, Usage & Precautions
Adwe Feverx Acetaminophen Caplets, 500 Mg Extra Strength Product Label
The following document was submitted to the FDA by the labeler of this product Aurex Laboratories Limited Liability Company. 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.
Otc - Active Ingredient
Active Ingredient: Acetaminophen 500 mg
Otc - Purpose
Uses:
- temporarily relives minor aches and pains
- temporarily reduces fever
Warnings
Liver warninig: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets in 24 hours. Severe liver damage may occur if you take:
- more than 8 caplets (4,000 mg of acetaminophen) in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks 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.
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.
Otc - When Using
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 - Keep Out Of Reach Of Children
Keep out of reach of children. 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 symptoms.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Dosage & Administration
Directions:
- do not take more than directed
- adults and children 12 years and over: take 1-2 caplets every 4-6 hours, as needed. Do not take more than 6 caplets in 24 hours, unless directed by a doctor.
- children under 12 years: ask a doctor
Storage And Handling
Other information
- Store at 20° C - 25° C (68° F - 77° F)
Inactive Ingredient
Inactive ingredients:
microcrystalline cellulose, vegetable magnesium stearate. May contain povidone.
How Supplied
* This product is not manufactured or distributed by the owner of the registered trademark TYLENOL®.
Distributed By:
Adwe Laboratories
1274 49 St. Brooklyn, NY 11219
This product contains no animal, soybean, or grain derivatives.
This product does not contain any Chometx or Krtnius.
REV 0221
* Please review the disclaimer below.