SUNMARK 12 HOUR ALLERGY RELIEF- clemastine fumarate tablet

SUNMARK 12 HOUR ALLERGY RELIEF by

Drug Labeling and Warnings

SUNMARK 12 HOUR ALLERGY RELIEF by is a Otc medication manufactured, distributed, or labeled by Strategic Sourcing Services LLC. 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, lactose monohydrate, povidone, pregelatinized starch, starch, stearic acid

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Tavist® Allergy active ingredient

12 Hour Allergy Relief

Clemastine Fumarate Tablets, USP 1.34 mg

Antihistamine

Relieves: Runny Nose, Sneezing

Itchy, Watery Eyes, Itchy Throat

Allergy

INGREDIENTS AND APPEARANCE

SUNMARK 12 HOUR ALLERGY RELIEF 
clemastine fumarate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-686
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 (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: 49348-686-03	2 in 1 CARTON	07/03/2003
1		8 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	07/03/2003

Labeler - Strategic Sourcing Services LLC (116956644)