FEVERALL- acetaminophen suspension
TARO PHARMACEUTICALS U.S.A., INC.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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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
Warnings
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
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.
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
Ask a doctor before use if your child has liver disease
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
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.
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)* |
|
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, FD&C red #40, 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
Dist. by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
NEW
ORAL
SUSPENSION
LIQUID
NDC 51672-5319-8
CHILDREN'S
ages 2-11 years
FeverAll®
ACETAMINOPHEN (160 mg/5 mL)
Pain Reliever/Fever Reducer
Oral Suspension
Cherry Flavor
DOSING CUP
ENCLOSED
4 FL OZ (118 mL)
TARO PHARMACEUTICALS U.S.A., INC.