Label: SILADRYL ALLERGY MEDICINE- diphenhydramine hydrochloride liquid

  • NDC Code(s): 54838-135-40, 54838-135-70, 54838-135-80
  • Packager: Lannett Company, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 April 23, 2018

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  • ACTIVE INGREDIENT

    Active Ingredient: Diphenhydramine HCl 12.5 mg (in each 5 mL (teaspoonful)(TSP))

  • PURPOSE

    Purpose: Antihistamine

  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
      • runny nose
      • sneezing
      • itchy, watery eyes
      • itching of the nose or throat
  • Warnings

    Do not use

    • to make a child sleepy
    • with any other product containing diphenhydramine, even one used on skin.
  • ASK DOCTOR

    Ask a doctor before use if you have

    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
    • a sodium restricted diet
  • ASK DOCTOR/PHARMACIST

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

  • WHEN USING

    When using this product

    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children
  • PREGNANCY OR BREAST FEEDING

    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 (1-800-222-1222).

  • Directions

    • repeat dose every 4 to 6 hours
    • do not take more than 6 doses in any 24-hour period
    • Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

     adults and children 12 years and over
     2 to 4 teaspoonfuls (TSP)
     children 6 to under 12 years
     1 to 2 teaspoonfuls (TSP)
     children under 6 years
     DO NOT USE

    Other information
    Each 5 mL (1 TSP) contains: Sodium 14 mg. Store at room temperature 20°-25°C (68°-77°F).

  • Inactive ingredients

    citric acid, D&C red no. 33, FD&C red no. 40, black cherry flavor, methylparaben, propylene glycol, propylparaben, saccharin sodium, sodium citrate, sorbitol, water.

  • SPL UNCLASSIFIED SECTION

    Questions

    1-844-834-0530

    Manufactured by:
    Silarx Pharmaceuticals, Inc.
    Carmel, NY 10512

    10-1043  Rev. 04/18

  • PRINCIPAL DISPLAY PANEL


    10-1043 Rev. 04/18

    Siladryl Allergy 118 mL 10-1043 Rev. 04/18


  • INGREDIENTS AND APPEARANCE
    SILADRYL ALLERGY MEDICINE 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54838-135
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (black cherry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54838-135-40118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/199711/30/2024
    2NDC:54838-135-70237 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/199711/30/2024
    3NDC:54838-135-80473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/199711/30/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/199711/30/2024
    Labeler - Lannett Company, Inc. (002277481)