NDC 51660-058 Guaifenesin And Pseudoephedrine Hcl

Guaifenesin And Pseudoephedrine Hcl

NDC Product Code 51660-058

NDC CODE: 51660-058

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)
ORANGE (C48331 - ORANGE TO LIGHT ORANGE)
Shape: OVAL (C48345)
Size(s):
17 MM
Imprint(s):
058
Score: 1

NDC Code Structure

  • 51660 - Ohm Laboratories, Inc.
    • 51660-058 - Guaifenesin And Pseudoephedrine Hcl

NDC 51660-058-18

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

NDC Product Information

Guaifenesin And Pseudoephedrine Hcl with NDC 51660-058 is a a human over the counter drug product labeled by Ohm Laboratories, Inc.. 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: Ohm Laboratories, 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.

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 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.

  • CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • HYPROMELLOSE 2910 (10000 MPA.S) (UNII: 0HO1H52958)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

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: Ohm Laboratories, Inc.
Labeler Code: 51660
FDA Application Number: ANDA212542 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: 04-01-2021 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: 12-31-2021 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

Otc - Purpose

Active ingredients (in each extended-release bi-layer tablet)PurposesGuaifenesin 600 mgExpectorantPseudoephedrine HCl 60 mgNasal DecongestantActive ingredients (in each extended-release bi-layer tablet)PurposesGuaifenesin 1200 mgExpectorantPseudoephedrine HCl 120 mgNasal 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 cold •hay fever •upper 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 contains an MAOI, ask a doctor or pharmacist before taking this product.Ask a doctor before use if you have •heart disease •high blood pressure •thyroid disease •diabetes •trouble urinating due to an enlarged prostate gland •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 directedStop use and ask a doctor if •you get nervous, dizzy, or sleepless •symptoms 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.

Directions

  • •do not crush, chew, or break tablet •take with a full glass of water •this product can be administered without regard for timing of meals •For 600 mg/60 mg: adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours •For 1200 mg/120 mg: adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 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 missing. •store between 20-25°C (68-77°F)

Inactive Ingredients

Carbomer homopolymer, NF; FD&C Yellow #6; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF

Questions?

Call 1-800-406-7984You may also report side effects to this phone number.Keep the carton. It contains important information.See end panel for expiration date.†Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.Distributed by:Ohm Laboratories Inc.New Brunswick, NJ 089010219

Guaifenesin 600 Mg And Pseudoephedrine Hcl 60 Mg Extended-Release Bi-Layer Tablets - Carton Label

  • NDC 51660-058-18†Compare Tothe active ingredients ofMucinex® Dohm®Guaifenesin 600 mg & Pseudoephedrine HCl 60 mgExtended-Release Bi-Layer TabletsExpectorant & Nasal Decongestant12 Hour •Clears Nasal/Sinus Congestion •Thins and Loosens Mucus •Immediate and Extended Release18 Extended-Release Bi-Layer Tablets†Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

Guaifenesin 1200 Mg And Pseudoephedrine Hcl 120 Mg Extended-Release Bi-Layer Tablets - Carton Label

  • NDC 51660-057-12†Compare Tothe active ingredients ofMucinex® Dohm®Maximum StrengthGuaifenesin 1200 mg & Pseudoephedrine HCl 120 mgExtended-Release Bi-Layer TabletsExpectorant & Nasal Decongestant12 Hour •Clears Nasal/Sinus Congestion •Thins and Loosens Mucus •Immediate and Extended Release12 Extended-Release Bi-Layer Tablets†Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

* Please review the disclaimer below.