FDA Label for Feverall Infants
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH RECTAL SUPPOSITORY)
- PURPOSES
- USES
- LIVER WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- STOP USE AND ASK A DOCTOR IF
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 6 SUPPOSITORY BLISTER PACK CARTON
Feverall Infants 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
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.
For rectal use only.
Dist. by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532
Active Ingredient (In Each Rectal Suppository)
Acetaminophen, USP 80 mg
Purposes
Pain reliever/fever reducer
Uses
temporarily
- reduces fever
- relieves minor aches, pains, and headache
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if your child takes
- more than 4 doses in 24 hours, which is the maximum daily amount for ages 6 to 11 months
- more than 5 doses in 24 hours, which is the maximum daily amount for ages 12 to 36 months
- with other drugs containing acetaminophen
Do Not Use
- if you are allergic to acetaminophen.
- 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
- the child has liver disease.
- the child is taking the blood thinning drug warfarin.
Stop Use And Ask A Doctor If
- fever lasts more than 3 days (72 hours), or recurs.
- pain lasts more than 3 days or gets worse.
- new symptoms occur.
- redness or swelling is present in the painful area.
These may be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms.
Directions
- this product does not contain directions or warnings for adult use
- do not use more than directed
- remove wrapper
- carefully insert suppository well up into the rectum
Age | Dose |
---|---|
under 6 months | Do not use unless directed by a doctor |
6 to 11 months | Use 1 suppository every 6 hours (maximum of 4 doses in 24 hours) |
12 to 36 months | Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours) |
Other Information
- store at 2°-27°C (35°-80°F)
- do not use if imprinted suppository wrapper is opened or damaged
Inactive Ingredients
glycerol monostearate, hydrogenated vegetable oil, polyoxyethylene stearate, polysorbate 80
Questions?
call 1-866-923-4914
Principal Display Panel - 6 Suppository Blister Pack Carton
NDC 51672-2114-2
RECTAL
SUPPOSITORY*
*actual size
Doctor Recommended
Pain Reliever/Fever Reducer
✓ No Parabens or Any Other Preservatives✓ No Artificial Colors
INFANTS'
ages 6-36 months
FeverAll®
ACETAMINOPHEN SUPPOSITORIES
Pain Reliever/Fever Reducer
6
Rectal
Suppositories
80
mg
each
* Please review the disclaimer below.