ALLERGY RELIEF DIPHENHYDRAMINE HCL- diphenhydramine hydrochloride capsule, liquid filled

Allergy Relief Diphenhydramine HCl by

Drug Labeling and Warnings

Allergy Relief Diphenhydramine HCl by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 110, LLC. DBA Leader. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each softgel)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

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

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

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.

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

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

SPL UNCLASSIFIED SECTION

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

Packaging

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF DIPHENHYDRAMINE HCL 
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0585
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	yellow (pale yellow transparent)	Score	no score
Shape	OVAL (oblong)	Size	15mm
Flavor		Imprint Code	780
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0585-1	2 in 1 CARTON	09/15/2021
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/15/2021

Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)