NDC 36800-442 Topcare Tab Tussin DM

Dextromethorphan Hydrobromide / Guaifenesin

NDC Product Code 36800-442

NDC CODE: 36800-442

Proprietary Name: Topcare Tab Tussin DM 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: Dextromethorphan Hydrobromide / Guaifenesin 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.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: OVAL (C48345)
Size(s):
17 MM
Imprint(s):
PH073
Score: 2

NDC Code Structure

  • 36800 - Topco Associates Llc

NDC 36800-442-24

Package Description: 2 BLISTER PACK in 1 CARTON > 12 TABLET in 1 BLISTER PACK

NDC Product Information

Topcare Tab Tussin DM with NDC 36800-442 is a a human over the counter drug product labeled by Topco Associates Llc. The generic name of Topcare Tab Tussin DM is dextromethorphan hydrobromide / guaifenesin. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Topco Associates 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.

Topcare Tab Tussin DM 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.

  • DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1
  • GUAIFENESIN 400 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • POVIDONE K30 (UNII: U725QWY32X)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

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: Topco Associates Llc
Labeler Code: 36800
FDA Application Number: part341 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: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 05-06-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Topcare Tab Tussin DM Product Label Images

Topcare Tab Tussin DM 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 - (Per Tablet)

Dextromethorphan Hydrobromide   20mg   Cough SuppressantGuaifenesin  400mg  Expectorant

Ask Doctor Before Use

If you have persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysmacough is accompanied by excessive phlegm (mucous)

Stop Use And Ask Doctor If

Symptoms are accompanied by fever, rash or persistent headachecough persists for more than 1 week or tends to recurA persistent cough may be a sign of a serious condition

Do Not Use

Do not use if you are now taking a prescription monoamine oxidase (inhiMor~MAIO)Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's diseaseor for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug containsan MAIO, ask your doctor or pharmacist before using this product.

Keep Out Of Reach Of Children,

In case of overdose, get medical help or contact a Poison Center immediately

Pregnant Or Breastfeeding

If pregnant or breastfeeding, ask a health professional before use.

Inactive Ingredients

Magnesium stearate, maltodextrin, microcrystalline cellulose, povidone K30, povidone 90F, silicon dioxide, stearic acid.

Directions

• Adults and children 12 years of age and over:     take 1 tablet every 4 hours as needed     • Children 610 under 12 years of age: take 1/2 tablet every 4 hours as needed • Children under 6 years of age: consult a doctor     Do not exceed 6 doses in a 24 hour period or as directed by a doctor Other information store at 15'- 30' C (59'- 86'F)     Rev 10/U9 RCCF

Uses

  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common coldhelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucushelps make coughs more productive

Purpose

Cough SuppressantExpectorant

Warning

Do not use if you are now taking a prescription monoamine oxidase (inhiMor~MAIO)Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's diseaseor for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug containsan MAIO, ask your doctor or pharmacist before using this product.

* Please review the disclaimer below.