Equate 44-599

Equate 44-599
SPL v18
SPL
SPL Set ID 53a3e6a7-d625-4393-95eb-bb6f86e86cc1
Route
ORAL
Published
Effective Date 2026-01-27
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 Active Since 2011-04-25 Until 2021-01-26
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?

1-888-287-1915

Principal Display Panel

NDC 49035-599-09

equate™

Compare

to Children's

Benadryl®

Chewables active

ingredient*



children's

ALLERGY RELIEF

Diphenhydramine HCl, 12.5 mg

Chewable Tablets

Antihistamine

6 YEARS AND OLDER

Relief of:

• Sneezing  • Runny nose  

• Itchy throat or nose

• Itchy, watery eyes

Cherry Flavored

20 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

*This product is not manufactured or distributed by Johnson & Johnson

Corporation, owner of the registered trademark Children’s Benadryl® Chewables.

50844                REV1218C59909

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716

Satisfaction guaranteed - Or we'll replace it or

give you your money back. For questions or

comments or to report an undesired reaction

or side effect, please call 1-888-287-1915.

Equate 44-599
When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic beverages

  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • 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 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?)

1-888-287-1915

Principal Display Panel

NDC 49035-599-09

equate™

Compare

to Children's

Benadryl®

Chewables active

ingredient*



children's

ALLERGY RELIEF

Diphenhydramine HCl, 12.5 mg

Chewable Tablets

Antihistamine

6 YEARS AND OLDER

Relief of:

• Sneezing  • Runny nose  

• Itchy throat or nose

• Itchy, watery eyes

Cherry Flavored

20 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

*This product is not manufactured or distributed by Johnson & Johnson

Corporation, owner of the registered trademark Children’s Benadryl® Chewables.

50844                REV1218C59909

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716

Satisfaction guaranteed - Or we'll replace it or

give you your money back. For questions or

comments or to report an undesired reaction

or side effect, please call 1-888-287-1915.

Equate 44-599
When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic beverages

  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • 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 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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:23.110189 · Updated: 2026-03-14T23:12:36.957432