NDC 72559-001 Curist Mucus Relief

Guaifenesin

NDC Product Code 72559-001

NDC Code: 72559-001

Proprietary Name: Curist Mucus 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: 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: CAPSULE (C48336)
Size(s):
17 MM
Imprint(s):
G233
Score: 1

NDC Code Structure

  • 72559 - Little Pharma, Inc.
    • 72559-001 - Curist Mucus Relief

NDC 72559-001-03

Package Description: 3 BLISTER PACK in 1 CARTON > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

NDC Product Information

Curist Mucus Relief with NDC 72559-001 is a a human over the counter drug product labeled by Little Pharma, Inc.. The generic name of Curist Mucus Relief is guaifenesin. The product's dosage form is tablet, extended release and is administered via oral form.

Labeler Name: Little Pharma, Inc.

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.

Curist Mucus 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.

  • GUAIFENESIN 600 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.

  • CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
  • HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POVIDONE (UNII: FZ989GH94E)

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: Little Pharma, Inc.
Labeler Code: 72559
FDA Application Number: ANDA209215 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: 06-05-2019 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: 12-31-2020 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’.

* Please review the disclaimer below.

Curist Mucus Relief Product Label Images

Curist Mucus 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

Other

Drug Facts

Distributed by:Little Pharma, Inc.New York, NY 10023

Otc - Active Ingredient

Active ingredient (in each extended release tablet)Guaifenesin 600 mg

Otc - Purpose

PurposeExpectorant

Indications & Usage

Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Warnings

Otc - Do Not Use

  • Do not use for children under 12 years of age

Otc - Ask Doctor

  • Ask a doctor before use if you havepersistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus)

Otc - Stop Use

  • Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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).

Dosage & Administration

  • Directionsdo not crush, chew, or break tablettake with a full glass of waterthis product can be administered without regard for the timing of mealsadults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.children under 12 years of age: do not use

Storage And Handling

  • Other informationtamper evident: do not use if carton is open or if printed seal on blister is broken or missingstore between 20 to 25°C (68 to 77°F)

Inactive Ingredient

Inactive ingredients carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

Otc - Questions

Questions? 1-844-243-1241
You may also report side effects to this phone number.

* Please review the disclaimer below.

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