NDC 62011-0382 Guaifenesin Extended Release 600 Mg

Guaifenesin

NDC Product Code 62011-0382

NDC Code: 62011-0382

Proprietary Name: Guaifenesin Extended Release 600 Mg 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):
22 MM
Imprint(s):
G233
Score: 1

NDC Code Structure

  • 62011 - Strategic Sourcing Services Llc
    • 62011-0382 - Guaifenesin Extended Release 600 Mg

NDC 62011-0382-1

Package Description: 4 BLISTER PACK in 1 CARTON > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

NDC Product Information

Guaifenesin Extended Release 600 Mg with NDC 62011-0382 is a a human over the counter drug product labeled by Strategic Sourcing Services Llc. The generic name of Guaifenesin Extended Release 600 Mg is guaifenesin. The product's dosage form is tablet, extended release and is administered via oral form.

Labeler Name: Strategic Sourcing Services Llc

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 Extended Release 600 Mg 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: Strategic Sourcing Services Llc
Labeler Code: 62011
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: 10-17-2019 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.

Guaifenesin Extended Release 600 Mg Product Label Images

Guaifenesin Extended Release 600 Mg 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 Extended-Release Tablet)

Guaifenesin 600 mg

Purpose

Expectorant

Use(S)

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

Warning

.

Do Not Use

For children under 12 years of age

Ask A Doctor Before Use If You Have

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

Stop Use And A Ask 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.

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 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 to 2 tablets every 12 hours.  Do not exceed 4 tablets in 24 hours.children under 12 years of age: do not use

Other Information

  • Tamper 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 Ingredients

Carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

Questions?

1-609-860-2600Hours: 8am - 4pm, ESTYou may also report side effects to this phone number.

* Please review the disclaimer below.