FDA Label for Infants Silapap
View Indications, Usage & Precautions
Infants Silapap Product Label
The following document was submitted to the FDA by the labeler of this product Atlantic Biologicals Corps. 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.
Otc - Active Ingredient
Active Ingredient: Acetaminophen 80 mg (in each 0.8 mL)
Otc - Purpose
Purpose: Fever reducer/pain reliever
Uses
temporarily:
■ reduces fever
■ relieves minor aches and pains due to: ■the common cold ■flu ■toothaches ■sore throat ■headaches
Warnings
This product contains acetaminophen. Severe liver damage may occur if your child takes:
Liver warning:
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
: 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. Sore throat warning
Do Not Use
- with any other product 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
liver disease. taking the blood thinning drug warfarin.
Ask a doctor before use if your child has
Ask a doctor or pharmacist before use if your child is
When Using This Product
- do not exceed recommended dosage. (see overdose warning)
Stop Use And Ask A Doctor If
■ new symptoms occur ■ redness or swelling is present ■ pain gets worse or lasts for more than 5 days ■ fever gets worse or lasts for more than 3 days.
These could be signs of serious condition.
Otc - Keep Out Of Reach Of Children
.
Keep out of reach of children
: 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. Overdose warning
Directions
■ ■ ■ find right dose on chart, if possible use weight to dose; otherwise, use age ■ use only enclosed dropper designed for use with this product, do not use any other dosing device ■ fill to dose level ■ dispense liquid slowly into child's mouth, toward inner cheek ■ may be given alone or mixed with formula, milk, juice etc. ■ If needed, repeat dose every 4 hours ■ do not give more than 5 times in 24 hours ■ Replace dropper tightly to maintain child resistance
this product does not contain directions or complete warnings for adult use
do not give more than directed (see overdose warning)
| Weight (lb) | Age (yr)
| Dose (mL) |
| under 24
| under 2 years
| ask a doctor
|
| 24-35
| 2-3 years
| 1.6 mL (0.8 + 0.8 mL)
|
For accurate dosing follow dosing instructions using the enclosed dropper. Fill dropper to 0.8 mL or prescribed level, and dispense with a single firm squeeze of the dropper bulb. Store between 20° - 25°C (68° - 77°F)
Other information
Inactive Ingredients
citric acid, FD&C yellow no. 6, cherry flavor, methylparaben, saccharin sodium, sodium benzoate, sodium citrate, propylene glycol and purified water.
Comments
1-888-974-5279
Manufactured by:
Silarx Pharmaceuticals, Inc. 1033 Stoneleigh Ave. Carmel , NY 10512
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