INFANTS SILAPAP  - acetaminophen solution/ drops 
Silarx Pharmaceuticals, Inc

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Infant's Silapap Drops

Drug Facts

Active ingredient               Purposes (in each 0.8 mL)

Acetaminophen 80 mg.......... Fever reducer/pain reliever

Uses

temporarily:

■ reduces fever

■ relieves minor aches and pains due to:

Warnings


Liver warning:


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

Ask a doctor before use if your child has
Ask a doctor or pharmacist before use if your child is

When using this product

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
■ 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)


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.
19 West St.
Spring Valley , NY 10977


Carton


Carton


Container


Container



INFANTS SILAPAP 
acetaminophen   solution/ drops
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 54838-145
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 80 mg  in 0.8 mL
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid  
FD&C yellow no. 6  
methylparaben  
saccharin sodium  
sodium benzoate  
sodium citrate  
propylene glycol  
water  
Product Characteristics
Color      Score     
Shape Size
Flavor CHERRY (wild cherry) Imprint Code
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 54838-145-15 15 mL In 1 BOTTLE, DROPPER None
2 54838-145-30 30 mL In 1 BOTTLE, DROPPER None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 04/01/1997

Labeler - Silarx Pharmaceuticals, Inc (161630033)
Revised: 06/2010 Silarx Pharmaceuticals, Inc