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Clemastine Fumarate by Physicians Total Care, Inc.

Medically reviewed on May 21, 2018

Dosage form: tablet
Ingredients: CLEMASTINE FUMARATE 1.34mg
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-5913

Drug Facts

Active ingredient

Clemastine fumarate 1.34 mg (equivalent to 1 mg clemastine)

Purpose

Antihistamine

Keep out of reach of children.

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

Uses

Temporarily relieves these symptoms of the common cold, hay fever, or other upper respiratory allergies:

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

Warnings

Ask a doctor before use if you have
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product
  • you may get drowsy
  • avoid alcoholic drinks
  • 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.

Directions

adults and children 12 years and older:

1 tablet every 12 hours; not more than 2 tablets in 24 hours

children under 12 years:

ask a doctor

Other Information
  • Safety sealed: do not use if the imprinted bottle seal is open or torn.
  • Store at 20°-25°C (68°-77°F).

Inactive Ingredients

Hydroxypropyl methylcellulose, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and starch (corn).

Questions or comments?

1-800-525-8747

PRINCIPAL DISPLAY PANEL

NDC 54868-5913-0

Clemastine

Fumarate

Tablets, USP

1.34 mg

100 Tablets


Antihistamine

12 Hour Relief

Relief of: Sneezing Runny Nose

Itchy, Watery Eyes



CLEMASTINE FUMARATE 
clemastine fumarate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-5913(NDC:0781-1358)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLEMASTINE FUMARATE (CLEMASTINE) CLEMASTINE FUMARATE1.34 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
STARCH, CORN 
CELLULOSE, MICROCRYSTALLINE 
HYPROMELLOSE 2910 (3 MPA.S) 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
MAGNESIUM STEARATE 
Product Characteristics
ColorWHITEScore2 pieces
ShapeCAPSULE (capsule shaped) Size4mm
FlavorImprint CodeGG;159
Contains    
Packaging
#Item CodePackage Description
1NDC:54868-5913-0100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07345806/27/2008
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel

 
Physicians Total Care, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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