Label: SILADRYL ALLERGY MEDICINE- diphenhydramine hydrochloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 1, 2024

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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:
    •
    o
    runny nose
    o
    sneezing
    o
    itchy, watery eyes
    o
    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

    Relabeled by:
    Proficient Rx LP
    Thousand Oaks, CA 91320

    10-1043  Rev. 04/18

  • PRINCIPAL DISPLAY PANEL

    71205-410-04

    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:71205-410(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, UNSPECIFIED FORM (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:71205-410-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/25/202011/30/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/01/199711/30/2024
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(71205-410) , RELABEL(71205-410)
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