Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 047102c4-3d03-4b2d-961d-0ac75980147b
Route
ORAL
Published
Effective Date 2023-10-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-03-31

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
    • runny 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 (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 skin
  • to make a child sleepy
Product Label
DOLLAR GENERAL HEALTH Children's Allergy Bubble Gum
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, RD&C red#40, flavors, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, and sucrose

Questions Or Comments?

 Call 1-888-309-9030

Principal Display Panel

Compare to active ingredient of Children's Benadryl® Allergy*

For Ages 6 to 11 Years

Children's

Allergy

Diphenhydramine HCI

Antihistamine 

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itching of the nose or throat

Alcohol free

Provides allergy symptom relief

Bubble Gum Flavor

FOR AGES 6-11

Dosing Cup included

FL OZ (mL)

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

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

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

When Using This Product
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
Active Ingredient (in Each 5 Ml)

Diphenhydramine HCl 12.5 mg

Keep Out of the Reach of Children.

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

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
    • runny 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 (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 skin
  • to make a child sleepy
Product Label
DOLLAR GENERAL HEALTH Children's Allergy Bubble Gum
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, RD&C red#40, flavors, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, and sucrose

Questions Or Comments? (Questions or comments?)

 Call 1-888-309-9030

Principal Display Panel

Compare to active ingredient of Children's Benadryl® Allergy*

For Ages 6 to 11 Years

Children's

Allergy

Diphenhydramine HCI

Antihistamine 

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itching of the nose or throat

Alcohol free

Provides allergy symptom relief

Bubble Gum Flavor

FOR AGES 6-11

Dosing Cup included

FL OZ (mL)

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

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

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

When Using This Product (When using this product)
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Diphenhydramine HCl 12.5 mg

Keep Out of the Reach of Children. (Keep out of the reach of children.)

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

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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