Dollar General 44-018

Dollar General 44-018
SPL v4
SPL
SPL Set ID 218c447e-9ddd-428a-9b33-0acec35e0d1b
Route
ORAL
Published
Effective Date 2025-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Propylene Glycol Water Sodium Benzoate Sodium Chloride Trisodium Citrate Dihydrate Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-06

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
  • find right dose on chart below
  • mL = milliliter
  • only use the dose cup provided
  • 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
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
Inactive Ingredients

anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum

Questions Or Comments?

1-888-309-9030

Principal Display Panel

DG™ health

Compare to active

ingredient of

Children’s Benadryl®

Dye-Free Allergy*

For Ages 6 to 11 Years

Children's

Allergy

Diphenhydramine HCl

12.5 mg per 5 mL

Oral Solution

Antihistamine

Relieves:

• Sneezing

• Runny nose

• Itchy, watery eyes

• Itchy nose or throat

Dye free/Alcohol free

4 FL OZ (118 mL)

Bubble Gum

Flavor

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by

Kenvue Inc., owner of the registered trademark

Children’s Benadryl® Dye-Free Allergy.

50844 ORG012301836

DISTRIBUTED BY

OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Dollar general 44-018

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
  • a breathing problem such as chronic bronchitis
  • glaucoma
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
  • find right dose on chart below
  • mL = milliliter
  • only use the dose cup provided
  • 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
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
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-888-309-9030

Principal Display Panel (Principal display panel)

DG™ health

Compare to active

ingredient of

Children’s Benadryl®

Dye-Free Allergy*

For Ages 6 to 11 Years

Children's

Allergy

Diphenhydramine HCl

12.5 mg per 5 mL

Oral Solution

Antihistamine

Relieves:

• Sneezing

• Runny nose

• Itchy, watery eyes

• Itchy nose or throat

Dye free/Alcohol free

4 FL OZ (118 mL)

Bubble Gum

Flavor

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by

Kenvue Inc., owner of the registered trademark

Children’s Benadryl® Dye-Free Allergy.

50844 ORG012301836

DISTRIBUTED BY

OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Dollar general 44-018

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)
  • a breathing problem such as chronic bronchitis
  • glaucoma
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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