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 June 9, 2023

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

View All Sections
  • Active ingredient

    (in each 10 mL cup)
    Diphenhydramine HCl 25 mg

  • 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 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 a doctor or pharmacist before use

    if you are taking sedatives or tranquilizers

  • 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
  • If pregnant or breast-feeding,

    ask a health professional before use.

  • 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

    • find right dose on chart below
    • take every 4 to 6 hours
    • do not take more than 6 doses in any 24-hour period

    adults and children 12 years and over

    1 cup (10 mL) to 2 cups (20 mL)

    children 6 to under 12 years

    1/2 cup (5 mL) to 1 cup (10 mL)

    children under 6 years

    DO NOT USE

  • Other information

    • Each 10 mL cup contains: Sodium 28 mg.
    • Store between 20° to 25°C (68° to 77°F).
    • Protect from light.
    • DO NOT USE IF SEAL IS BROKEN.
    • This drug product is supplied in 10 mL unit dose cups as:
      30 cups (3 x 10) NDC 60687-267-08
      100 cups (10 x 10) NDC 60687-267-56
  • 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.

  • PACKAGING INFORMATION

    American Health Packaging unit dose cups contain drug product Siladryl Allergy (Diphenhydramine Hydrochloride) from Silarx Pharmaceuticals, Inc. as follows:
    (25 mg per 10 mL / 30 UD) NDC 60687-267-08packaged from NDC 54838-135
    (25 mg per 10 mL / 100 UD) NDC 60687-267-56 packaged from NDC 54838-135

    Distributed by:
    American Health Packaging
    Columbus, OH 43217

    8426769/1121F

  • Principal Display Panel

    Diphenhydramine Hydrochloride Tray Label

    Diphenhydramine
    Hydrochloride
    Liquid
    Antihistamine

    •Sugar Free • Alcohol Free

    FOR INSTITUTIONAL USE ONLY

    Store between
    20° and 25°C (68° and 77°F).
    Protect from light.

    8426769/1121F

  • Principal Display Panel – Cup - 25 mg per 10 mL/10 mL

    25 mg per 10 mL Diphenhydramine Hydrochloride Liquid Cup Label

    NDC 60687- 267-42

    Diphenhydramine
    Hydrochloride Liquid
    Antihistamine

    25 mg / 10 mL
    Delivers 10 mL

    Sugar Free. Alcohol Free.

    See package Drug Facts insert for
    information and storage.

    For Institutional Use Only.

    American Health Packaging
    Columbus, OH 43217

    0426769/0221

  • INGREDIENTS AND APPEARANCE
    SILADRYL ALLERGY MEDICINE 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60687-267(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)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    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)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (black cherry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60687-267-5610 in 1 CASE06/05/202011/30/2024
    1NDC:60687-267-4810 in 1 TRAY
    1NDC:60687-267-4210 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:60687-267-083 in 1 CASE03/01/202210/31/2024
    2NDC:60687-267-4810 in 1 TRAY
    2NDC:60687-267-4210 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/05/202011/30/2024
    Labeler - American Health Packaging (929561009)
    Establishment
    NameAddressID/FEIBusiness Operations
    American Health Packaging929561009repack(60687-267)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!