NDC 30142-137 Guaifenesin And Pseudoephedrine Hcl

Guaifenesin And Pseudoephedrine Hcl

NDC Product Code 30142-137

NDC CODE: 30142-137

Proprietary Name: Guaifenesin And Pseudoephedrine Hcl 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 Pseudoephedrine Hcl 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 - WHITE TO OFF-WHITE)
Shape: OVAL (C48345)
Size(s):
14 MM
Imprint(s):
64;X
Score: 1

NDC Code Structure

NDC 30142-137-12

Package Description: 1 BLISTER PACK in 1 CARTON > 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

NDC 30142-137-17

Package Description: 2 BLISTER PACK in 1 CARTON > 18 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

NDC Product Information

Guaifenesin And Pseudoephedrine Hcl with NDC 30142-137 is a a human over the counter drug product labeled by Kroger Company. The generic name of Guaifenesin And Pseudoephedrine Hcl is guaifenesin and pseudoephedrine hcl. The product's dosage form is tablet, extended release and is administered via oral form.

Labeler Name: Kroger Company

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 Pseudoephedrine Hcl 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
  • PSEUDOEPHEDRINE HYDROCHLORIDE 60 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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
  • MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
  • POVIDONE K25 (UNII: K0KQV10C35)
  • POVIDONE K90 (UNII: RDH86HJV5Z)
  • STARCH, CORN (UNII: O8232NY3SJ)

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: Kroger Company
Labeler Code: 30142
FDA Application Number: ANDA213203 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: 04-16-2021 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 Pseudoephedrine Hcl 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)      Guaifenesin USP 600 mg                                                                                      Pseudoephedrine HCl USP 60 mg

Purposes

ExpectorantNasal Decongestant

Uses

  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves nasal congestion due to:common coldhay feverupper respiratory allergies temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage temporarily relieves sinus congestion and pressure

Warnings

Do not use 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

  • Heart diseasehigh blood pressurethyroid diseasediabetestrouble urinating due to an enlarged prostate glandpersistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysemacough accompanied by too much phlegm (mucus)

When Using This Product

  • Do not use more than directed

Stop Use And Ask A Doctor If

  • You get nervous, dizzy, or sleeplesssymptoms do not get better within 7 days, come back or occur with a 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 timing of mealsadults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hourschildren under 12 years of age: do not use

Other Information

  • Tamper evident: do not use if carton is opened or if individual blister units are torn or opened. store at 20 to 25°C (68 to 77°F)

Inactive Ingredients

Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinised starch (maize).

Questions?

1-800-632-6900 You may also report side effects to this phone number.DISTRIBUTED BYTHE KROGER CO.CINCINNATI, OHIO 45202MADE IN INDIA Code: AP/DRUGS/04/2016

* Please review the disclaimer below.