Rite Aid 44-599

Rite Aid 44-599
SPL v20
SPL
SPL Set ID aa7164a7-f842-457d-abee-0740bb8c1c90
Route
ORAL
Published
Effective Date 2025-08-18
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 2021-09-16

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
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy
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

Compare to the active ingredient in Children’s Benadryl® Chewables*

NDC 11822-0599-4

6 YEARS & OLDER

CHILDREN’S

ALLERGY
RELIEF

DIPHENHYDRAMINE HCI 12.5 mg

CHEWABLE TABLETS

ANTIHISTAMINE

for relief of: sneezing • runny nose

itchy, watery eyes

itchy throat or nose

ACTUAL SIZE

CHERRY

FLAVOR

18

CHEWABLE TABLETS

CONTAINS ONE

ACTIVE INGREDIENT

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 Kenvue Inc., owner of

the registered trademark Children’s Benadryl® Chewables. 50844 REV1218F59944

DISTRIBUTED BY: RITE AID,

200 NEWBERRY COMMONS

ETTERS, PA 17319

www.riteaid.com

SATISFACTION

GUARANTEE

I
f you’re not satisfied, we’ll

happily refund your money.

Rite Aid 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)
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy
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

Compare to the active ingredient in Children’s Benadryl® Chewables*

NDC 11822-0599-4

6 YEARS & OLDER

CHILDREN’S

ALLERGY
RELIEF

DIPHENHYDRAMINE HCI 12.5 mg

CHEWABLE TABLETS

ANTIHISTAMINE

for relief of: sneezing • runny nose

itchy, watery eyes

itchy throat or nose

ACTUAL SIZE

CHERRY

FLAVOR

18

CHEWABLE TABLETS

CONTAINS ONE

ACTIVE INGREDIENT

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 Kenvue Inc., owner of

the registered trademark Children’s Benadryl® Chewables. 50844 REV1218F59944

DISTRIBUTED BY: RITE AID,

200 NEWBERRY COMMONS

ETTERS, PA 17319

www.riteaid.com

SATISFACTION

GUARANTEE

I
f you’re not satisfied, we’ll

happily refund your money.

Rite Aid 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)