Equaline 44-585 Delisted

Equaline 44-585 Delisted
SPL v16
SPL
SPL Set ID e34d8bf5-e12e-453c-93ea-9c7988c4f13d
Route
ORAL
Published
Effective Date 2025-09-16
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 Fd&c Blue No. 1 Aluminum Lake Hydroxypropyl Cellulose, Unspecified Magnesium Stearate Mannitol Stearic Acid Sucralose Sucrose

Identifiers & Packaging

Pill Appearance
Imprint: 44;585 Shape: round Color: purple Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2009-03-20 Until 2027-04-30

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:
    • itchy, watery eyes
    • runny nose
    • 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • 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, FD&C blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

Questions Or Comments?

1-855-423-2630

Principal Display Panel

EQUALINE®

compare to

Children’s Benadryl®

Chewables

active ingredient*

NDC 41163-585-44

children's

allergy relief

diphenhydramine HCl 12.5 mg

chewable tablets

(antihistamine)

for ages 6-11

grape flavor

relieves:

• sneezing        • itchy throat

• runny nose    • itchy, watery eyes

18 chewable tablets

actual size

CHEW OR CRUSH TABLETS COMPLETELY BEFORE SWALLOWING.

DO NOT SWALLOW TABLETS WHOLE.

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         REV1218C58544

100% Quality

GUARANTEED

Like it or let us make it right.

That’s our quality promise.

855-423-2630

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

Equaline 44-585
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 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:
    • itchy, watery eyes
    • runny nose
    • 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • 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, FD&C blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

Questions Or Comments? (Questions or comments?)

1-855-423-2630

Principal Display Panel

EQUALINE®

compare to

Children’s Benadryl®

Chewables

active ingredient*

NDC 41163-585-44

children's

allergy relief

diphenhydramine HCl 12.5 mg

chewable tablets

(antihistamine)

for ages 6-11

grape flavor

relieves:

• sneezing        • itchy throat

• runny nose    • itchy, watery eyes

18 chewable tablets

actual size

CHEW OR CRUSH TABLETS COMPLETELY BEFORE SWALLOWING.

DO NOT SWALLOW TABLETS WHOLE.

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         REV1218C58544

100% Quality

GUARANTEED

Like it or let us make it right.

That’s our quality promise.

855-423-2630

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

Equaline 44-585
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 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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