Quality Choice 44-015

Quality Choice 44-015
SPL v2
SPL
SPL Set ID 66a1a94d-5d7a-49ba-96a4-bab89779296a
Route
ORAL
Published
Effective Date 2025-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-11

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


Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Other Information
  • each 5 mL contains: sodium 4 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
  • protect from light

Inactive Ingredients

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

Questions Or Comments?

1-800-426-9391

Principal Display Panel

NDC 83324-326-04

QUALITY

CHOICE

Compare to the

Active Ingredient in

Children’s Benadryl®

Allergy*

Children’s

Allergy

Relief

Diphenhydramine HCl 12.5 mg

per 5 mL Oral Solution

Antihistamine

Relieves:

Sneezing, Runny Nose,

Itchy, Watery Eyes,

Itchy Throat or Nose

For Ages 6 to 11 Years

Alcohol

Free

Cherry Flavored

4 FL OZ (118 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED

NECK WRAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Kenvue Inc.,

owner of the registered trademark Children’s Benadryl® Allergy.

50844 ORG072401536

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Quality choice 44-015
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 right away.

Active Ingredient (in Each 5 Ml)

Diphenhydramine HCl 12.5 mg

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


Do Not Use (Do not use)
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Other Information (Other information)
  • each 5 mL contains: sodium 4 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
  • protect from light

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

NDC 83324-326-04

QUALITY

CHOICE

Compare to the

Active Ingredient in

Children’s Benadryl®

Allergy*

Children’s

Allergy

Relief

Diphenhydramine HCl 12.5 mg

per 5 mL Oral Solution

Antihistamine

Relieves:

Sneezing, Runny Nose,

Itchy, Watery Eyes,

Itchy Throat or Nose

For Ages 6 to 11 Years

Alcohol

Free

Cherry Flavored

4 FL OZ (118 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED

NECK WRAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Kenvue Inc.,

owner of the registered trademark Children’s Benadryl® Allergy.

50844 ORG072401536

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Quality choice 44-015
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 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)
  • glaucoma
  • a breathing problem such as chronic bronchitis

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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