Allergy Relief Diphenhydramine Hcl

Allergy Relief Diphenhydramine Hcl
SPL v3
SPL
SPL Set ID ad437177-08eb-4811-883f-ac543d5bc58c
Route
ORAL
Published
Effective Date 2021-09-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Gelatin, Unspecified Glycerin Isopropyl Alcohol Medium-chain Triglycerides Polyethylene Glycol, Unspecified Povidone, Unspecified Water Sorbitol Sorbitan

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-09-15

Description

Diphenhydramine HCl 25 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCl 25 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 temporarily relieves these symptoms due to the common cold: •runny nose •sneezing

Section 42229-5

LEADER

DYE-FREE

Relief of: Sneezing, Runny Nose, Itchy, Watery Eyes, Itchy Throat

COMPARE TO BENADRYL® DYE-FREE ALLERGY active ingredient*

100% Money Back Guarantee

READ AND KEEP OUTER PACKAGE FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl® Dye-Free Allergy.

All LEADERTM Brand Products Have A 100% Money Back Guarantee

Return to place of purchase if not satisfied.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Product of UAE

Packaged and Quality Assured in the USA

©2021 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS SIGNS OF TAMPERING

Section 50565-1

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Warnings

Do not use •to make a child sleepy

•with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

•a breathing problem such as emphysema or chronic bronchitis •glaucoma

•difficulty in urination due to enlargement to the prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

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

Packaging

Directions

•take every 4 to 6 hours, or as directed by a doctor

•do not take more than 6 doses in 24 hours

adults and children 12 years and older  1 to 2 softgels
children 6 to under 12 years  1 softgel
children under 6 years  do not use

Drug Facts

Other Information

•store at 25°C (77°F) in a dry place

•protect from light, heat and moisture

Inactive Ingredients

edible white ink, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution

Questions Or Comments?

1-888-577-8033 Monday-Friday 8am-4pm EST

Active Ingredient (in Each Softgel)

Diphenhydramine HCl 25 mg


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 temporarily relieves these symptoms due to the common cold: •runny nose •sneezing

Section 42229-5 (42229-5)

LEADER

DYE-FREE

Relief of: Sneezing, Runny Nose, Itchy, Watery Eyes, Itchy Throat

COMPARE TO BENADRYL® DYE-FREE ALLERGY active ingredient*

100% Money Back Guarantee

READ AND KEEP OUTER PACKAGE FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl® Dye-Free Allergy.

All LEADERTM Brand Products Have A 100% Money Back Guarantee

Return to place of purchase if not satisfied.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Product of UAE

Packaged and Quality Assured in the USA

©2021 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS SIGNS OF TAMPERING

Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Purpose

Antihistamine

Warnings

Do not use •to make a child sleepy

•with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

•a breathing problem such as emphysema or chronic bronchitis •glaucoma

•difficulty in urination due to enlargement to the prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

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

Packaging

Directions

•take every 4 to 6 hours, or as directed by a doctor

•do not take more than 6 doses in 24 hours

adults and children 12 years and older  1 to 2 softgels
children 6 to under 12 years  1 softgel
children under 6 years  do not use

Drug Facts

Other Information (Other information)

•store at 25°C (77°F) in a dry place

•protect from light, heat and moisture

Inactive Ingredients (Inactive ingredients)

edible white ink, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution

Questions Or Comments? (Questions or comments?)

1-888-577-8033 Monday-Friday 8am-4pm EST

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Diphenhydramine HCl 25 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)