SUNMARK 12 HOUR ALLERGY RELIEF- clemastine fumarate tablet 
Strategic Sourcing Services LLC

----------

McKesson 12 Hour Allergy Relief Drug Facts

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

12 Hour Allergy Relief Carton
SUNMARK 12 HOUR ALLERGY RELIEF 
clemastine fumarate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-686
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLEMASTINE FUMARATE (UNII: 19259EGQ3D) (CLEMASTINE - UNII:95QN29S1ID) CLEMASTINE FUMARATE1.34 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITE (off white) Score2 pieces
ShapeCAPSULESize9mm
FlavorImprint Code L282
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-686-032 in 1 CARTON07/03/200301/28/2020
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07451207/03/200301/28/2020
Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 5/2021
 
Strategic Sourcing Services LLC