Label: SILADRYL ALLERGY MEDICINE - diphenhydramine hydrochloride liquid 

  • NDC Code(s): 54838-135-40, 54838-135-70, 54838-135-80
  • Packager: Silarx Pharmaceuticals, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/14

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

  • ACTIVE INGREDIENT

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

    Close
  • PURPOSE

    Purpose: Antihistamine

    Close
  • 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
    Close
  • Warnings

    Do not use

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

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

    Close
  • 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
    Close
  • PREGNANCY OR BREAST FEEDING

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

    Close
  • 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).

    Close
  • 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).

    Close
  • 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.

    Close
  • SPL UNCLASSIFIED SECTION

    Questions

    888-974-5279

    Manufactured by:
    Silarx Pharmaceuticals, Inc.
    1033 Stoneleigh Ave
    Carmel, NY 10512
    USA

    Close
  • INGREDIENTS AND APPEARANCE
    SILADRYL ALLERGY MEDICINE 
    diphenhydramine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54838-135
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    diphenhydramine hydrochloride (diphenhydramine) diphenhydramine hydrochloride 12.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    anhydrous citric acid  
    methylparaben  
    propylene glycol  
    propylparaben  
    saccharin sodium dihydrate  
    sodium citrate  
    sorbitol  
    water  
    D&C red no. 33  
    FD&C red no. 40  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY (black cherry) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54838-135-40 118 mL in 1 BOTTLE
    2 NDC:54838-135-70 237 mL in 1 BOTTLE
    3 NDC:54838-135-80 473 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 01/01/1997
    Labeler - Silarx Pharmaceuticals, Inc (161630033)
    Close