Otc - Active Ingredient
Active Ingredient: Acetaminophen 80 mg (in each 0.8 mL)
The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corps for the product Infants Silapap (NDC 17856-0145). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredient: Acetaminophen 80 mg (in each 0.8 mL)
Purpose: Fever reducer/pain reliever
temporarily:
■ reduces fever
■ relieves minor aches and pains due to: ■the common cold ■flu ■toothaches ■sore throat ■headaches
This product contains acetaminophen. Severe liver damage may occur if your child takes:
Liver 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. Sore throat warning
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
■ 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.
.
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
■ ■ ■ 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
citric acid, FD&C yellow no. 6, cherry flavor, methylparaben, saccharin sodium, sodium benzoate, sodium citrate, propylene glycol and purified water.
1-888-974-5279
Manufactured by:
Silarx Pharmaceuticals, Inc. 1033 Stoneleigh Ave. Carmel , NY 10512
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