LEADER ALLERHIST- clemastine fumarate tablet

Leader Allerhist by

Drug Labeling and Warnings

Leader Allerhist 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)

Clemastine fumarate, USP 1.34 mg (equivalent to 1 mg clemastine)

Purpose

Antihistamine

Uses

temporarily reduces these symptoms of the common cold, hay fever, and other respiratory allergies:

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

Warnings

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to an enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

• avoid alcoholic drinks
• drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful 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.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 12 years of age and over: take 1 tablet every 12 hours; not more than 2 tablets in 24 hours unless directed by a doctor
• children under 12 years of age: consult a doctor

Other information

• sodium free
• store at 15°-30°C (59°-86°F)

Inactive ingredients

colloidal silicon dioxide, corn starch, lactose monohydrate, povidone, pregelatinized starch, stearic acid

Questions or comments?

1-800-719-9260

Principal Display Panel

12 Hour Allerhist

Clemastine Fumarate Tablets, USP 1.34 mg Antihistamine

12 Hour Relief of:

Runny Nose

Sneezing

Itchy, watery eyes

Itchy throat

COMPARE TO TAVIST® ALLERGY active ingredient

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16 TABLETS

INGREDIENTS AND APPEARANCE

LEADER ALLERHIST 
clemastine fumarate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0216
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLEMASTINE FUMARATE (UNII: 19259EGQ3D) (CLEMASTINE - UNII:95QN29S1ID)	CLEMASTINE FUMARATE	1.34 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE (off white)	Score	2 pieces
Shape	CAPSULE	Size	9mm
Flavor		Imprint Code	L282
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0216-1	16 in 1 CARTON	01/11/2017
1		1 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
ANDA	ANDA074512	01/11/2017

Labeler - Cardinal Health (097537435)