Clemastine Fumarate
FDA Label NDC 54868-5913

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Clemastine Fumarate (NDC 54868-5913). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, keep out of reach of children., uses, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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

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Clemastine Fumarate 1.34 mg Label (5913)

Clemastine Fumarate 1.34 mg Label (5913)

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



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