Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID 714e93ec-0aa9-4be2-9311-399e82f148e0
Route
ORAL
Published
Effective Date 2026-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Water D&c Red No. 33 Sodium Benzoate Sucrose Fd&c Red No. 40 Poloxamer 407 Sodium Chloride Trisodium Citrate Dihydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2015-03-31 Until 2026-11-28

Description

Diphenhydramine HCl 12.5 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 12.5 mg

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
Directions
  • do not take more than 6 doses in 24 hours
  • take every 4 to 6 hours, or as directed by a doctor
  • measure only with dosing cup provided. Do not use any other dosing device
  • mL = milliliter
  • keep dosing cup with product
  • find the right dose on the chart below
age (yr)  Dose (mL)
children 6 to 11 years 5 mL to 10 mL
children 2 to 5 years do  not use unless directed by a doctor
children under 2 years do not use


Do Not Use
  • with any other product containing diphenhydramine, even one used on the skin
  • to make a child sleepy
Package Label
BEST CHOICE Children's Allergy Cherry Flavor
Other Information
  • each 5 mL contains: sodium 6 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate 
  • Protect from light. Store in outer carton until contents are used.
Inactive Ingredients

anhydrous 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 1-877-753-3935 Monday-Friday 9AM-5PM EST 

Principal Display Panel

Compare to the active ingredient in Children's Benadryl® Allergy**

Children's Allergy

Diphenhydramine HCl 12.5 mg/5 mL

Antihistamine

Oral Solution

For relief of:

  • Sneezing
  • Runny nose
  • Itchy, water eyes
  • Itchy of the nose or throat

Cherry Flavor

For ages 6 to 11 years

Alcohol Free

FL OZ (mL)

Dosing Cup Included

*This product is not manufactured or distributed by McNeil Consumer Healthcare, Inc., distributor of Benadryl® Allergy.

TAMPER EVIDENT: DO NOT USE IF IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

PROUDLY DISTRIBUTED BY:

ASSOCIATED WHOLESALE GROCERS, INC.

KANSAS CITY, KANSAS 66106

When Using This Product
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredient (in Each 5 Ml)

Diphenhydramine HCl 12.5 mg

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


Structured Label Content

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
Purpose

Antihistamine

Directions
  • do not take more than 6 doses in 24 hours
  • take every 4 to 6 hours, or as directed by a doctor
  • measure only with dosing cup provided. Do not use any other dosing device
  • mL = milliliter
  • keep dosing cup with product
  • find the right dose on the chart below
age (yr)  Dose (mL)
children 6 to 11 years 5 mL to 10 mL
children 2 to 5 years do  not use unless directed by a doctor
children under 2 years do not use


Do Not Use (Do not use)
  • with any other product containing diphenhydramine, even one used on the skin
  • to make a child sleepy
Package Label
BEST CHOICE Children's Allergy Cherry Flavor
Other Information (Other information)
  • each 5 mL contains: sodium 6 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate 
  • Protect from light. Store in outer carton until contents are used.
Inactive Ingredients (Inactive ingredients)

anhydrous 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? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

Principal Display Panel

Compare to the active ingredient in Children's Benadryl® Allergy**

Children's Allergy

Diphenhydramine HCl 12.5 mg/5 mL

Antihistamine

Oral Solution

For relief of:

  • Sneezing
  • Runny nose
  • Itchy, water eyes
  • Itchy of the nose or throat

Cherry Flavor

For ages 6 to 11 years

Alcohol Free

FL OZ (mL)

Dosing Cup Included

*This product is not manufactured or distributed by McNeil Consumer Healthcare, Inc., distributor of Benadryl® Allergy.

TAMPER EVIDENT: DO NOT USE IF IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

PROUDLY DISTRIBUTED BY:

ASSOCIATED WHOLESALE GROCERS, INC.

KANSAS CITY, KANSAS 66106

When Using This Product (When using this product)
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Diphenhydramine HCl 12.5 mg

Ask A Doctor Before Use If the Child Has (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 (Ask a doctor or pharmacist before use if the child is)

taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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