Label: SILADRYL ALLERGY MEDICINE- diphenhydramine hydrochloride liquid

  • 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 February 9, 2011

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

  • ACTIVE INGREDIENT

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

    * 5 mL = 1 teaspoonful

  • 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
    • temporarily relieves these symptoms due to common cold:
      • runny nose
      • sneezing
  • Warnings

    Do not use with any other product containing diphenhydramine, including one applied topically.

  • 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.

  • Directions

    • repeat dose every 4 to 6 hours
    • do not take more than 6 doses in any 24-hour period
    adults and children 12 years and over
    2 to 4 teaspoonfuls
    children 6 to under 12 years
    1 to 2 teaspoonfuls
    children under 6 years
    DO NOT USE

    Other information

    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

    888-974-5279

    † This product is not manufactured or distributed by Warner-Lambert Consumer Healthcare, owner of the registered trademark Benadryl®.

    Manufactured by:
    Silarx Pharmaceuticals, Inc.
    19 West Street
    Spring Valley, NY 10977
    USA

    Repackaged by:

    Rebel Distributors Corp

    Thousand Oaks, CA 91320

  • Principal Display Panel

    Diphenhydramine 12.5mg/5ml

  • INGREDIENTS AND APPEARANCE
    SILADRYL ALLERGY MEDICINE 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-689(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:21695-689-04118 mL in 1 BOTTLE
    2NDC:21695-689-16473 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/1997
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK