Label: DIPHENHYDRAMINE ORAL LIQUID- diphenhydramine hydrochloride liquid

  • NDC Code(s): 57237-305-12, 57237-305-16
  • Packager: Rising Pharma Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 18, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient in each 5 mL ( in one teaspoonful)

    Diphenhydramine HCl, 12.5 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

    temporarily relieves these symptoms due to the common cold:

    • runny nose
    • sneezing
  • Warnings

    Do not use

    • 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.

    Directions

    • take every 4-6 hours
    • Do not use more than 6 dose in 24 hours
    adults and children 12 years of age and over2 to 4 teaspoonfuls (25 to 50 mg)
    children 6 to under 12 years of age1 to 2 teaspoonfuls (12.5 to 25 mg)
    children under 6 yearsask a doctor

  • Other information

    • store at room temperature 15º - 30ºC (59º - 86ºF)
    • protect from freezing
    • protect from light
    • each teaspoon (5 mL) contains: sodium 8 mg

    TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

  • Inactive ingredients

    cherry flavor, citric acid, D & C Red #33, FD & C Red #40, flavor, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, sucrose, water.

    Questions or comments?

    1-844-474-7464

  • PRINCIPAL DISPLAY PANEL

    Rising Health, LLC

    NDC 57237-305-12

    Diphenhydramine Hcl 12.5 mg/5 mL Oral Solution

    4 fl oz (118 mL)diphenhydramine-label

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE ORAL LIQUID 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-305
    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)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Sorbitol (UNII: 506T60A25R)  
    Sucrose (UNII: C151H8M554)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorPINK (dark pink to pink) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57237-305-12118 mL in 1 BOTTLE; Type 0: Not a Combination Product12/19/2022
    2NDC:57237-305-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/19/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM009.5012/19/2022
    Labeler - Rising Pharma Holdings, Inc. (116880195)
    Establishment
    NameAddressID/FEIBusiness Operations
    Invahealth Inc.116840615manufacture(57237-305) , pack(57237-305) , label(57237-305) , analysis(57237-305)
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