Label: SILAFED- pseudoephedrine hydrochloride and triprolidine hydrochloride syrup

  • NDC Code(s): 54838-101-40, 54838-101-70
  • Packager: Lannett Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 December 2, 2010

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

  • ACTIVE INGREDIENT

    Active Ingredient: Pseudoephedrine hydrochloride 30 mg (in each 5 mL)
    Active Ingredient: Triprolidine hydrochloride 1.25 mg (in each 5 mL)

  • PURPOSE

    Purpose of Pseudoephedrine hydrochloride: Nasal Decongestant
    Purpose of Triprolidine hydrochloride: Antihistamine

  • INDICATIONS & USAGE

    Uses temporary relieves nasal congestion due to:

    • common cold
    • hay fever
    • other upper respiratory allergies
    • temporarily dries runny nose
    • temporarily relives:
      • sneezing
      • runny nose
      • itchy watery eyes and nose
  • Warnings

    Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

  • ASK DOCTOR

    Ask a doctor before use if you have

    • breathing problem such as emphysema or chronic bronchitis
    • heart diseases
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor before use if you are taking sedatives or tranquilizers

  • WHEN USING

    When using this product

    • drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • may cause excitability in children
    • do not use more than directed
  • STOP USE

    Stop use and ask a doctor if

    • symptoms do not improve within 7 days or accompanied by fever
    • nervousness, dizziness or sleeplessness occurs
  • PREGNANCY

    If pregnant or breast-feeding, ask a health professional before use. 

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Take dosage every 6 hours or as directed by doctor.

     Adults and children 12 years and over
     2 teaspoonfuls
     Children  under 12 years
     DO NOT USE
  • Other Information

    Store at controlled room temperature 20°-25°C (68°-77°F). Protect from freezing.

  • Inactive Ingredients

    citric acid, D&C yellow no. 10, methylparaben, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sodium hydroxide, sucrose, and water.

  • Questions

    888-974-5279

  • PRINCIPAL DISPLAY PANEL


    Container Label 118mL

    Container Label 237mL
  • INGREDIENTS AND APPEARANCE
    SILAFED 
    pseudoephedrine hydrochloride and triprolidine hydrochloride syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54838-101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE1.25 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54838-101-40118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/05/1988
    2NDC:54838-101-70237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/05/1988
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34110/05/1988
    Labeler - Lannett Company, Inc. (161630033)