Infants silapap solution/ drops

Otc - active ingredient section

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

Otc - purpose section

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.


Otc - keep out of reach of children section

. 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 - 25C (68 - 77F)

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


Ingredients and appearance - Product information

Infants silapap solution/ drops- Acetaminophen

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 17856-0145
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 80 mgin 0.8 mL

Inactive Ingredients

Ingredient Name Code
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

Flavor CHERRY (wild cherry)

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 17856-0145-3 1mL in 1 SYRINGE 2016/05/05

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part343 USA 2016/05/05

Labeler - Atlantic Biologicals Corps( 047437707)

Establishment

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

Infants silapap (acetaminophen) solution/ drops