Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID c573da1e-c7ca-46e6-ad42-4ded2547afc3
Route
ORAL
Published
Effective Date 2024-04-22
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

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-06-30

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:

  • sneezing
  • running nose
  • 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 (yrs)  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
QUALITY 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 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

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

Children's Allergy

Oral Solution

Diphenhydramine HCl 12.5 mg

Antihistamine

Relief of Runny Nose, Sneezing, Itchy Throat & Itchy, Watery Eyes

For Ages 6 to 11 Years

Alcohol Free

Cherry Flavor

FL OZ (mL)

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

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

Distributed by C.D.M.A., Inc.©

43157 W. Nine Mile

Novi, MI 48375-0995

www.qualitychoice.com

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:

  • sneezing
  • running nose
  • 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 (yrs)  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
QUALITY 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 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

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

Children's Allergy

Oral Solution

Diphenhydramine HCl 12.5 mg

Antihistamine

Relief of Runny Nose, Sneezing, Itchy Throat & Itchy, Watery Eyes

For Ages 6 to 11 Years

Alcohol Free

Cherry Flavor

FL OZ (mL)

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

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

Distributed by C.D.M.A., Inc.©

43157 W. Nine Mile

Novi, MI 48375-0995

www.qualitychoice.com

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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