Infants Silapap

Silarx Pharmaceuticals, Inc

Infant's Silapap Drops

FULL PRESCRIBING INFORMATION: CONTENTS*

• Infants Silapap Uses
• Warnings
• Do not use
• When using this product
• Stop use and ask a doctor if
• Directions
• Inactive ingredients
• Comments

FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredient: Acetaminophen 80 mg (in each 0.8 mL)

Purpose

Purpose: Fever reducer/pain reliever

Infants Silapap Uses

temporarily:

■ reduces fever

■ relieves minor aches and pains due to:
   ■the common cold ■flu ■toothaches ■sore throat ■headaches 

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

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 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

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 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.

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 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)
■ 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

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.

Other information
Store between 20° - 25°C (68° - 77°F)

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