Label: 7 SELECT ALLERGY CHILDRENS- diphenhydramine hcl solution

  • 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 September 9, 2019

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

  • Active ingredient (in each 5 mL)

    Diphenhydramine HCl 12.5 mg

  • Purpose

    Antihistamine

  • Uses

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

    a breathing problem such as chronic bronchitis
    glaucoma
    a sodium-restricted diet

    Ask a doctor or pharmacist before use if the child is

    taking 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 (1-800-222-1222).

  • Directions

    find right dose on chart below
    mL = milliliter
    take every 4 to 6 hours, or as directed by a doctor
    do not take more than 6 doses in 24 hours

    Age (yr)

    Dose (mL)

    children under 2 years

    do not use

    children 2 to 5 years

    do not use unless directed by a doctor

    children 6 to 11 years

    5 mL to 10 mL

    Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

  • Other information

    each 5 mL contains: sodium 15 mg
    store at 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.
    do not use if printed neckband is broken or missing
  • Inactive ingredients

    anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare to Children’s Benadryl® active ingredient

    Children’s

    Allergy Liquid

    12.5 mg/5 mL

    Diphenhydramine HCl

    Oral Solution

    Antihistamine

    Relieves

    Runny Nose

    Sneezing

    Itchy, Watery Eyes

    Itchy Throat

    Ages 6 to 11

    Alcohol Free

    Cherry Flavored Liquid

    Dosage Cup Included

    4-6 Hours/Dose

    4 FL OZ (118 mL)

    7 Select Children's Allergy Liquid image
  • INGREDIENTS AND APPEARANCE
    7 SELECT ALLERGY  CHILDRENS
    diphenhydramine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10202-379
    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)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorRED (Bluish-Red) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10202-379-261 in 1 CARTON08/05/201404/30/2021
    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 finalpart34108/05/201404/30/2021
    Labeler - 7-Eleven (007347602)