Infants Silapap description, usages, side effects, indications, overdosage, supplying and lots more!

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Infants Silapap

Silarx Pharmaceuticals, Inc

Infant's Silapap Drops


FULL PRESCRIBING INFORMATION: CONTENTS*




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

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.

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


Infants Silapap


Infants Silapap

Acetaminophen SOLUTION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54838-145
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 80 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
FD&C YELLOW NO. 6
METHYLPARABEN
SACCHARIN SODIUM DIHYDRATE
SODIUM BENZOATE
SODIUM CITRATE
propylene glycol
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54838-145-15 15 in 1 BOTTLE, DROPPER
2 NDC:54838-145-30 30 in 1 BOTTLE, DROPPER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 1997-04-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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