Meijer 44-599

Meijer 44-599
SPL v15
SPL
SPL Set ID 5d6998f7-51ea-4422-9944-45b075343e57
Route
ORAL
Published
Effective Date 2025-09-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
D&c Red No. 27 Aluminum Lake D&c Red No. 30 Aluminum Lake Dextrose Monohydrate Ethylcellulose, Unspecified Hydroxypropyl Cellulose, Unspecified Magnesium Stearate Mannitol Stearic Acid Sucralose Sucrose

Identifiers & Packaging

Pill Appearance
Imprint: 44;599 Shape: round Color: pink Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2011-04-25 Until 2026-06-30

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:
    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
Directions
  • find right dose on chart below
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
Age (yr)

Dose (chewable tablets)

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 1 to 2 chewable tablets

(12.5 mg to 25 mg)

adults and children 12 years

and over

2 to 4 chewable tablets

(25 mg to 50 mg)
Do Not Use
  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin
Other Information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid high humidity

  • see end flap for expiration date and lot number
Inactive Ingredients

D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

Questions Or Comments?

1-800-426-9391

Principal Display Panel

meijer®

NDC 41250-599-44

Compare to Children's

Benadryl® Chewables 

active ingredient*

CHILDREN'S

allergy relief

Diphenhydramine HCl | 12.5 mg Chewable Tablets

Antihistamine

Relieves: Sneezing, Itchy Throat, Runny Nose & Itchy, Watery Eyes

Cherry

Flavored

18 Chewable Tablets

Actual

Size

Chew or crush tablets completely

before swallowing.

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

DIST. BY MEIJER

DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544


www.meijer.com

OUR QUALITY

GUARANTEE

The Meijer

Family


WWW.MEIJER.COM/SATISFACTION

*This product is not manufactured or distributed by Johnson &

Johnson Corporation, owner of the registered trademark Children's

Benadryl® Chewables.

50844      REV1218B59944

Meijer 44-599
When Using This Product
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • avoid alcoholic beverages

  • excitability may occur, especially in children
If Pregnant Or Breast Feeding,

ask a health professional before use.

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.

Ask A Doctor Before Use If You Have
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland

Active Ingredient (in Each Chewable Tablet)

Diphenhydramine HCl 12.5 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.


Structured Label Content

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
Purpose

Antihistamine

Directions
  • find right dose on chart below
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
Age (yr)

Dose (chewable tablets)

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 1 to 2 chewable tablets

(12.5 mg to 25 mg)

adults and children 12 years

and over

2 to 4 chewable tablets

(25 mg to 50 mg)
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)
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid high humidity

  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

meijer®

NDC 41250-599-44

Compare to Children's

Benadryl® Chewables 

active ingredient*

CHILDREN'S

allergy relief

Diphenhydramine HCl | 12.5 mg Chewable Tablets

Antihistamine

Relieves: Sneezing, Itchy Throat, Runny Nose & Itchy, Watery Eyes

Cherry

Flavored

18 Chewable Tablets

Actual

Size

Chew or crush tablets completely

before swallowing.

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

DIST. BY MEIJER

DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544


www.meijer.com

OUR QUALITY

GUARANTEE

The Meijer

Family


WWW.MEIJER.COM/SATISFACTION

*This product is not manufactured or distributed by Johnson &

Johnson Corporation, owner of the registered trademark Children's

Benadryl® Chewables.

50844      REV1218B59944

Meijer 44-599
When Using This Product (When using this product)
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • avoid alcoholic beverages

  • excitability may occur, especially in children
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland

Active Ingredient (in Each Chewable Tablet) (Active ingredient (in each chewable tablet))

Diphenhydramine HCl 12.5 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

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