Label: KOSHER MEDS CHILDRENS ALLERGY RELIEF- diphenhydramine hcl solution

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 15, 2024

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  • Active Ingredient

    (in each 5 mL teaspoonful)
    Diphenhydramine HCl 12.5mg

  • Purpose

    Antihistamine

  • Uses

    • temporarily relieves these symptoms due to hay fever or other respiratory allergies:
    • sneezing
    • itching of the nose or throat
    • runny nose
    • itchy watery eyes
    • temporarily relieves these symptoms due to the common cold:
    • sneezing
    • runny nose
  • Warnings

    Do not use

    • with any other product containing diphenhydramine, even one used on skin
    • to make a child sleepy

    Ask a doctor before use if the child has

    • glaucoma
    • a breathing problem such as chronic bronchitis

    Ask a doctor or pharmacist before use if the child istaking sedatives or tranquilizers

    When using this product

    • marked drowsiness may occur
    • excitability may occur, especially in children
    • sedatives and tranquilizers may increase drowsiness

    Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    •  if needed, take every 4-6 hours
    • do not take more than 6 doses in 24 hours
     Children under 4 years of age: do not use
     Children 4 to under 6 years of age: do not use unless directed by a doctor
     Children 6 to under 12 years of age: 1 to 2 teaspoonfuls (12.5 mg to 25 mg)

  • Other Information

    • Keep carton for full directions for use
    • each teaspoonful contains: sodium 10 mg
    • store at 20° - 25° C (68° - 77° F)
    • dosage cup provided
  • Inactive ingredients

    Citric acid, D&C Red # 33, FD&C Red # 40, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

  • Questions or comments?

    Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

  • Product label

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    KOSHER MEDS CHILDRENS ALLERGY RELIEF 
    diphenhydramine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82179-004
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCROSE (UNII: C151H8M554)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82179-004-041 in 1 CARTON04/18/2024
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01304/18/2024
    Labeler - Mollec Inc (040088196)
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