NDC 0121-1276 Guaifenesin Dm
Guaifenesin And Dextromethorphan Syrup Oral
NDC Product Code 0121-1276
Proprietary Name: Guaifenesin Dm 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 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 InformationThe 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 non-narcotic, alcohol free expectorant/cough suppressant
Product Characteristics
Color(s):
RED (C48326)
Flavor(s):
CHERRY (C73375)
NDC Code Structure
- 0121 - Pharmaceutical Associates, Inc.
- 0121-1276 - Guaifenesin Dm
NDC 0121-1276-00
Package Description: 10 TRAY in 1 CASE > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (0121-1276-10)
NDC Product Information
Guaifenesin Dm with NDC 0121-1276 is a human over the counter drug product labeled by Pharmaceutical Associates, Inc.. The generic name of Guaifenesin Dm is guaifenesin and dextromethorphan. The product's dosage form is syrup and is administered via oral form.
Dosage Form: Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
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 Dm 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 a single concept unique identifier (RXCUI) is 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.
- CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
- FD&C RED NO. 40 (UNII: WZB9127XOA)
- GLYCERIN (UNII: PDC6A3C0OX)
- MENTHOL (UNII: L7T10EIP3A)
- WATER (UNII: 059QF0KO0R)
- SODIUM BENZOATE (UNII: OJ245FE5EU)
- SODIUM CITRATE (UNII: 1Q73Q2JULR)
- SACCHARIN SODIUM (UNII: SB8ZUX40TY)
- SUCROSE (UNII: C151H8M554)
- SODIUM BENZOATE (UNII: OJ245FE5EU)
- SODIUM CITRATE (UNII: 1Q73Q2JULR)
- SACCHARIN SODIUM (UNII: SB8ZUX40TY)
- SUCROSE (UNII: C151H8M554)
- CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
- FD&C RED NO. 40 (UNII: WZB9127XOA)
- GLYCERIN (UNII: PDC6A3C0OX)
- MENTHOL (UNII: L7T10EIP3A)
- WATER (UNII: 059QF0KO0R)
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.
- Decreased Respiratory Secretion Viscosity - [PE] (Physiologic Effect)
- Expectorant - [EPC] (Established Pharmacologic Class)
- Increased Respiratory Secretions - [PE] (Physiologic Effect)
- Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
- Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
- Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
Product Labeler Information
What is the Labeler Name?Name of Company corresponding to the labeler code segment of the Product NDC.
Labeler Name: Pharmaceutical Associates, Inc.
Labeler Code: 0121
FDA Application Number: part341 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: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 07-01-1992 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: 12-31-2023 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.
Information for Patients
Dextromethorphan
Dextromethorphan is pronounced as (dex troe meth or' fan)
Why is dextromethorphan medication prescribed?Guaifenesin
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat th...
[Read More]
Guaifenesin is pronounced as (gwye fen' e sin)
Why is guaifenesin medication prescribed?
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a cla...
[Read More]
* Please review the disclaimer below.
Guaifenesin Dm 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
- Description
- Uses
- Otc - Do Not Use
- Ask A Doctor Before Use If You Have
- Stop Use And Ask A Doctor If
- Otc - Pregnancy Or Breast Feeding
- Otc - Keep Out Of Reach Of Children
- Manufactured By
Otc - Purpose
Non-Narcotic, Alcohol Free
Expectorant/Cough Suppressant
Description
Each 5 mL (1 teaspoonful) contains:Guaifenesin100 mgDextromethorphan Hydrobromide10 mg
Uses
- Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productivetemporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
Otc - Do Not Use
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
- Cough that occurs with too much phlegm (mucus)cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Stop Use And Ask A Doctor If
- Cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.you are hypersensitive to any of the ingredients.
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.
Manufactured By
Pharmaceutical Associates, Inc.Greenville, SC 29605
www.paipharma.com
R11/16
* Please review the disclaimer below.