Smart sense childrens allergy relief solution

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 20-25C (68-77F). 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

Ingredients and appearance - Product information

Smart sense childrens allergy relief solution- Diphenhydramine hcl

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 49738-466
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Diphenhydramine hydrochloride ( UNII: TC2D6JAD40)( Diphenhydramine - UNII: 8GTS82S83M ) 12.5 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
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

Color RED (Bluish-Red) Flavor CHERRY

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA

Labeler - Kmart Corporation( 008965873)

Principal display panel

COMPARE TO ACTIVE INGREDIENT IN CHILDRENS BENADRYL® ALLERGY LIQUID

childrens

allergy relief

DIPHENHYDRAMINE HCl 12.5 mg/5 mL ORAL SOLUTION

ANTIHISTAMINE

4-6 HOURS/DOSE

CHERRY FLAVORED

ALCOHOL FREE

RELIEVES:

SNEEZING

ITCHY, WATERY EYES

RUNNY NOSE ITCHY THROAT

8 FL OZ (236 mL)