FDA Label for Feverall
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH 5 ML)
- PURPOSES
- USES
- LIVER WARNING
- SORE THROAT WARNING
- DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- STOP USE AND ASK A DOCTOR IF
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE CARTON
Feverall Product Label
The following document was submitted to the FDA by the labeler of this product Taro Pharmaceuticals U.s.a., 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
Dist. by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532
Active Ingredient (In Each 5 Ml)
Acetaminophen 160 mg
Purposes
Pain reliever/fever reducer
Uses
temporarily:
- reduces fever
- relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if your child takes:
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
Sore Throat Warning
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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 your child is allergic to acetaminophen or any of the inactive ingredients in this product
Otc - Ask Doctor
Ask a doctor before use if your child has liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
Otc - When Using
When using this product do not exceed recommended dose (see overdose warning)
Stop Use And Ask A Doctor If
- pain gets worse or lasts more than 5 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.
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. (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
- this product does not contain directions or complete warnings for adult use.
- do not give more than directed (see overdose warning)
- shake well before using
- mL = milliliter
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- do not give more than 5 days unless directed by a doctor.
Weight (lb) | Age (yr) | Dose (mL) or as directed by a doctor |
---|---|---|
under 24 | under 2 years | ask a doctor |
24-35 lbs | 2-3 years | 5 mL |
36-47 lbs | 4-5 years | 7.5 mL |
48-59 lbs | 6-8 years | 10 mL |
60-71 lbs | 9-10 years | 12.5 mL |
72-95 lbs | 11 years | 15 mL |
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
Other Information
- each 5 mL contains: sodium 3 mg
- store between 20 to 25°C (68 to 77°F)
- do not refrigerate
- Keep carton for full directions for use.
Inactive Ingredients
anhydrous citric acid, butylparaben, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
Questions?
Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944
Principal Display Panel - 118 Ml Bottle Carton
NEW
ORAL
SUSPENSION
LIQUID
NDC 51672-5320-8
CHILDREN'S
ages 2-11 years
FeverAll®
ACETAMINOPHEN (160 mg/5 mL)
Pain Reliever/Fever Reducer
Oral Suspension
Grape Flavor
DOSING CUP
ENCLOSED
4 FL OZ (118 mL)
* Please review the disclaimer below.