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

Purpose

Antihistamine

Description

Diphenhydramine HCl 12.5 mg


Medication Information

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)
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

Description

Diphenhydramine HCl 12.5 mg

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
Do Not Use
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy
Questions Or Comments?

1-800-426-9391

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)
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

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
Do Not Use (Do not use)
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy
Questions Or Comments? (Questions or comments?)

1-800-426-9391

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

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