LEADER ALLERGY- diphenhydramine hydrochloride capsule

Leader Allergy by

Drug Labeling and Warnings

Leader Allergy by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each capsule)

Diphenhydramine hydrochloride 25 mg

Purpose

Antihistamine

Uses

• temporarily relieves these symptoms of the common cold:
• • runny nose
  • sneezing
• temporarily relieves these symptoms due to hay fever or other respiratory allergies:
• • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy watery eyes.
    

Warnings

Do not use

• 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 an enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking tranquilizers or sedatives.

When using this product

• excitability may occur, especially in children
• drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• use caution when  operating machinery or driving a motor vehicle

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.

Directions

• take every 4 to 6 hours, not more than 6 doses in 24 hours

• adults and children 12 years of age and over: take 1 or 2 tablets
• children 6 to under 12 years of age: take 1 tablet
• children under 6 years of age: consult a doctor
• children under 4 years of age: do not use

Other information

• store at room temperature 15°-30°C (59°-86°F) in a dry place
  
• protect from light
• do not use if red band around capsule is broken or missing
  

Inactive ingredients

DandC Red No. 28, FDandC Blue No. 1, FDandC Red No. 40, gelatin, lactose, and starch.

Questions or comments?

*This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., owner of the registered trademark Benadryl Allergy Ultratabs.

Distributed by Cardinal Health

Dublin, OH 43017

www.myleader.com   1-800-200-6313

All leader brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

Package/Label Principal Display Panel

*Compare Benadryl® Allergy Kaplets active ingredient

Allergy Tablets

Diphenhydramine Hydrochloride 25 mg

Antihistimine

For Allergy Relief

Runny Nose, Sneezing, Itchy Throat, Itchy, watery eyes

24 Capsules

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

INGREDIENTS AND APPEARANCE

LEADER ALLERGY 
diphenhydramine hydrochloride capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-277
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
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
LACTOSE (UNII: J2B2A4N98G)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	PINK (clear) , WHITE (clear) , RED (band)	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	CPC835
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-277-62	2 in 1 CARTON
1		12 in 1 BLISTER PACK
2	NDC: 37205-277-78	1 in 1 CARTON
2		100 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/15/1990

Labeler - Cardinal Health (097537435)