INFANTS SILAPAP- acetaminophen solution/ drops

Infants Silapap by

Drug Labeling and Warnings

Infants Silapap by is a Otc medication manufactured, distributed, or labeled by Atlantic Biologicals Corps. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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.

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

INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS

INGREDIENTS AND APPEARANCE

INFANTS SILAPAP  
acetaminophen solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17856-0145(NDC:54838-145)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	80 mg  in 0.8 mL

Inactive Ingredients
Ingredient Name	Strength
anhydrous citric acid (UNII: XF417D3PSL)
FD&C yellow no. 6 (UNII: H77VEI93A8)
methylparaben (UNII: A2I8C7HI9T)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
sodium benzoate (UNII: OJ245FE5EU)
sodium citrate (UNII: 1Q73Q2JULR)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (wild cherry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17856-0145-3	1 mL in 1 SYRINGE; Type 0: Not a Combination Product	05/05/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	04/01/1997

Labeler - Atlantic Biologicals Corps (047437707)

Registrant - Atlantic Biologicals Corps (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
Atlantic Biologicals Corps		047437707	RELABEL(17856-0145) , REPACK(17856-0145)