LEADER ALLERGY- diphenhydramine hydrochloride tablet

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 tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose
• sneezing
  
• itchy, watery eyes
• itching of the nose or throat

temporarily relieves these symptoms due to the common cold:

• runny nose
• sneezing

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

• each tablet contains: calcium 25 mg/tablet
• store at room temperature 15°-30°C (59°-86°F)
• protect from light and moisture

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, DandC Red 27Aluminum Lake, dibasic calcium phosphate dihydrate, hypromellose, lecithin*, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, polyvinyl alcohol*, purified water*, talc*, and titanium dioxide

* contains one or more of these ingredients

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.

Package/Label Principal Display Panel

NDC: 63548-0070-1

*Compare to the active ingredient in Benadryl® Allergy Ultratabs®

Antihistamine

Allergy Tablets

Diphenhydramine Hydrochloride 25 mg

For Allergy Relief

Sneezing, Itchy, Watery Eyes, Runny Nose, Itchy Throat

12 Tablets

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 tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-270
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 (UNII: 2LRS185U6K)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL (UNII: 532B59J990)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	PINK (dark)	Score	no score
Shape	CAPSULE	Size	10mm
Flavor		Imprint Code	T61;V25;EL
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-270-62	2 in 1 CARTON
1		12 in 1 BLISTER PACK
2	NDC: 37205-270-78	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	05/11/1992

Labeler - Cardinal Health (097537435)