NDC 63304-110 Guaifenesin And Dextromethorphan Hbr

Tablet, Extended Release Oral

  1. Labeler Index
  2. Sun Pharmaceutical Industries, Inc.
  3. NDC: 63304-110 Guaifenesin And Dextromethorphan Hbr

NDC Product Code 63304-110

NDC CODE: 63304-110

Proprietary Name: Guaifenesin And Dextromethorphan Hbr 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: Guaifenesin And Dextromethorphan Hbr 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.
  • This product is used as cough suppressantexpectorant

Product Characteristics

Color(s):
WHITE (C48325 - OFF-WHITE)
Shape: OVAL (C48345)
Size(s):
16 MM
22 MM
Imprint(s):
054
053
Score: 1

NDC Code Structure

NDC 63304-110-14

Package Description: 1 BLISTER PACK in 1 CARTON > 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

NDC Product Information

Guaifenesin And Dextromethorphan Hbr with NDC 63304-110 is a human over the counter drug product labeled by Sun Pharmaceutical Industries, Inc.. The product's dosage form is tablet, extended release and is administered via oral form.

Dosage Form: Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.

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.

Guaifenesin And Dextromethorphan Hbr 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.

RxNorm Crosswalk

What is RxNorm?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) (RxCUI) to each NDC.

The RxNorm Crosswalk for this NDC code indicates multiple concept unique identifiers (RXCUI) are associated with this product:


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.
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • POVIDONE K30 (UNII: U725QWY32X)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • POVIDONE K30 (UNII: U725QWY32X)
  • 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.

Pharmacologic Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Product Labeler Information

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

Labeler Name: Sun Pharmaceutical Industries, Inc.
Labeler Code: 63304
FDA Application Number: ANDA214781 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: 07-01-2021 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.

Guaifenesin And Dextromethorphan Hbr Product Label Images

Guaifenesin And Dextromethorphan Hbr 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 Ingredients (In Each Extended-Release Tablet)

Dextromethorphan HBr 60 mgGuaifenesin 1200 mg

Purposes

Cough suppressantExpectorant

Uses

  • •helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive •temporarily relieves: •cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants •the intensity of coughing •the impulse to cough to help you get to sleep

Warnings

  • Do not use •for children under 12 years of age •if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have

  • •persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema •cough accompanied by too much phlegm (mucus)

When Using This Product

  • •Do not use more than directed

Stop Use And Ask A Doctor If

  • •cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

Pregnancy Or Breast Feeding

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 (1-800-222-1222).

Directions

  • •do not crush, chew, or break extended-release tablet •take with a full glass of water •this product can be administered without regard for timing of meals •adults and children 12 years and older: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours •children under 12 years of age: do not use

Other Information

  • •Store between 20-25°C (68-77°F)

Inactive Ingredients

Carbomer homopolymer, colloidal silicon dioxide, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), stearic acid

* Please review the disclaimer below.