SILAFED (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [LANNETT COMPANY, INC.]

SILAFED (PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE) SYRUP [LANNETT COMPANY, INC.]
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NDC 54838-101-40, 54838-101-70
Set ID b7c62fdd-5709-4023-9c30-6970de4ad2b3
Category HUMAN OTC DRUG LABEL
Packager Lannett Company, Inc.
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
  • 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)

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