FDA Label for Pediacare Infants Fever Reducer Dye Free
View Indications, Usage & Precautions
Pediacare Infants Fever Reducer Dye Free Product Label
The following document was submitted to the FDA by the labeler of this product Blacksmith Brands, 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.
Active Ingredients
(in each 0.8 mL)
Acetaminophen 80mg
Purpose
Pain reliever/fever reducer
Uses
temporarily:
- reduces fever
- relieves minor aches and pains due to:
- the common cold
- flu
- sore throat
- toothache
- headache
- the common cold
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if the 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, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do Not Use
- with any other product containing acetaminophen (prescription or non-prescription). 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.
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.
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 even if you do not notice any signs or symptoms.
Directions
- do not give more than directed (see overdose warning)
- shake well before use
- this product does not contain directions or complete warnings for adult use
- use only with enclosed dosing device
- fill to dose level
- dispense liquid slowly into child’s mouth towards inner cheek
- repeat dose every 4 hours if needed
- do not give more than 5 times in 24 hours
- do not give for more than 5 days unless directed by a doctor
- use dropper to close bottle and maintain child resistance
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
| Weight (lb) | Age (yr) | Dose (mL) |
| Under 24 | Under 2 | ask a doctor |
| 24-35 | 2-3 | 1.6 mL (0.8 + 0.8 mL) |
Other Information
store between 20-25°C (68-77°F)
Inactive Ingredients:
butyl paraben, citric acid, flavor, glycerin, maltitol, propylene glycol, propyl paraben, purified water, sucralose, xanthan gum.
Questions Or Comments?
call 1-888-474-3099
Distributed by:
Blacksmith Brands Inc.
200 White Plains Road
Tarrytown, NY 10591 USA
© 2010
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