FDA Label for Adwe Feverx
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS
- PRINCIPAL DISPLAY PANEL
Adwe Feverx Product Label
The following document was submitted to the FDA by the labeler of this product Syntho Pharmaceuticals, 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.
Other
Drug Facts
* This product is not manufactured or distributed by the owner of the registered trademark TYLENOL®. This products contain no animal, soybean or grain derivatives. THis product does not contains any Chometz or Kitnius.
KOSHER FOR PASSOVER
DIST BY: Adwe Laboratories
1274 49 St. Brooklyn, NY 11219
REV 201-0415
Active Ingredient (In Each Tablet)
Acetaminophen 500 mg
Purpose
Pain Reliever/Fever Reducer
Uses
- temporarily relieves minor aches and pains
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg (8 tablets) in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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 blood thinning drug warfarin
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.
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
Taking more than therecommended dose (overdose) may cause liver damage. In case of overdose get medical help or contact Poison Control Centre 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
do not take more than directed (see overdose warning)
adults & children 12 years and over:
- take 1-2 tablets every 4-6 hours as needed
- do not take more than 6 tablets in 24 hours
children under 12 years: do not use
Other Information
TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
- store at 20°C - 25°C (68°F - 77°F)
Inactive Ingredients
povidone. May also contain: cellulose, croscarmellose sodium, magnesium silicate, silica, vegetable magnesium starate
Questions Or Comments
Principal Display Panel
NDC 666576-200-01
KOSHER FOR PASSOVER
Adwe Feverx
Acetaminophen Tablets
PAIN RELIEVER FEVER REDUCER
EXTRA STRENGTH TABLETS
Compare to Active Ingredient in Extra Strength Tylenol®*
100 TABLETS 500 mg each
* Please review the disclaimer below.