NDC 49348-686 Sunmark 12 Hour Allergy Relief

Clemastine Fumarate

NDC Product Code 49348-686

NDC CODE: 49348-686

Proprietary Name: Sunmark 12 Hour Allergy Relief What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Clemastine Fumarate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Clemastine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms include rash, watery eyes, itchy eyes/nose/throat/skin, cough, runny nose, and sneezing. This medication works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. By blocking another natural substance made by your body (acetylcholine), it helps dry up some body fluids to relieve symptoms such as watery eyes and runny nose. Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

Product Characteristics

Color(s):
WHITE (C48325 - OFF WHITE)
Shape: CAPSULE (C48336)
Size(s):
9 MM
Imprint(s):
L282
Score: 2

NDC Code Structure

  • 49348 - Strategic Sourcing Services Llc

NDC 49348-686-03

Package Description: 2 BLISTER PACK in 1 CARTON > 8 TABLET in 1 BLISTER PACK

NDC Product Information

Sunmark 12 Hour Allergy Relief with NDC 49348-686 is a a human over the counter drug product labeled by Strategic Sourcing Services Llc. The generic name of Sunmark 12 Hour Allergy Relief is clemastine fumarate. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Strategic Sourcing Services Llc

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Sunmark 12 Hour Allergy Relief Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CLEMASTINE FUMARATE 1.34 mg/1

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Strategic Sourcing Services Llc
Labeler Code: 49348
FDA Application Number: ANDA074512 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-03-2003 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Clemastine

Clemastine is pronounced as (klem' as teen)

Why is clemastine medication prescribed?
Clemastine is used to relieve hay fever and allergy symptoms, including sneezing; runny nose; and red, itchy, tearing eyes. Prescription strength clemastine is also used ...
[Read More]

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Sunmark 12 Hour Allergy Relief Product Label Images

Sunmark 12 Hour Allergy Relief Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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

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 drowsinessbe careful when driving a motor vehicle or operating machineryexcitability 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 doctorchildren 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

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