Label: INFANTS SILAPAP- acetaminophen solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 5, 2016

If you are a consumer or patient please visit this version.

  • 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

    Label Image
  • INGREDIENTS AND APPEARANCE
    INFANTS SILAPAP  
    acetaminophen solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0145(NDC:54838-145)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen80 mg  in 0.8 mL
    Inactive Ingredients
    Ingredient NameStrength
    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    
    ShapeSize
    FlavorCHERRY (wild cherry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-0145-31 mL in 1 SYRINGE; Type 0: Not a Combination Product05/05/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/01/1997
    Labeler - Atlantic Biologicals Corps (047437707)
    Registrant - Atlantic Biologicals Corps (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    Atlantic Biologicals Corps047437707RELABEL(17856-0145) , REPACK(17856-0145)