Guaifenesin And Codeine Phosphate
Pharmaceutical Associates, Inc.
Human Otc Drug
NDC 0121-0775Guaifenesin And Codeine Phosphate is a human otc drug labeled by 'Pharmaceutical Associates, Inc.'. National Drug Code (NDC) number for Guaifenesin And Codeine Phosphate is 0121-0775. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Guaifenesin And Codeine Phosphate drug includes Codeine Phosphate - 10 mg/5mL Guaifenesin - 100 mg/5mL . The currest status of Guaifenesin And Codeine Phosphate drug is Active.
Drug Information:
| Drug NDC: | 0121-0775 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Guaifenesin And Codeine Phosphate |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Guaifenesin And Codeine Phosphate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Pharmaceutical Associates, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CODEINE PHOSPHATE - 10 mg/5mL
GUAIFENESIN - 100 mg/5mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 01 Oct, 2006 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part341 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Pharmaceutical Associates, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 995868
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000193956
N0000008867
N0000009560
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | GSL05Y1MN6
495W7451VQ
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class EPC: | Expectorant [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class PE: | Decreased Respiratory Secretion Viscosity [PE]
Increased Respiratory Secretions [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class: | Decreased Respiratory Secretion Viscosity [PE]
Expectorant [EPC]
Full Opioid Agonists [MoA]
Increased Respiratory Secretions [PE]
Opioid Agonist [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
| DEA Schedule: | CV |
| This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0121-0775-04 | 118 mL in 1 BOTTLE (0121-0775-04) | 01 Oct, 2006 | N/A | No |
| 0121-0775-08 | 237 mL in 1 BOTTLE (0121-0775-08) | 01 Oct, 2006 | N/A | No |
| 0121-0775-16 | 473 mL in 1 BOTTLE (0121-0775-16) | 01 Oct, 2006 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Active ingredients in each 5 ml (teaspoonful) purposes codeine phosphate, usp 10 mg cough suppressant guaifenesin, usp 100 mg expectorant
Product Elements:
Guaifenesin and codeine phosphate guaifenesin and codeine phosphate sodium citrate edetate disodium fd&c blue no. 1 fd&c red no. 40 fd&c yellow no. 6 glycerin menthol, unspecified form propylene glycol water sodium benzoate anhydrous citric acid saccharin sodium sorbitol guaifenesin guaifenesin codeine phosphate codeine anhydrous guaifenesin and codeine phosphate guaifenesin and codeine phosphate sodium citrate edetate disodium fd&c blue no. 1 fd&c red no. 40 fd&c yellow no. 6 glycerin menthol, unspecified form propylene glycol water sodium benzoate anhydrous citric acid saccharin sodium sorbitol guaifenesin guaifenesin codeine phosphate codeine anhydrous guaifenesin and codeine phosphate guaifenesin and codeine phosphate sodium citrate edetate disodium fd&c blue no. 1 fd&c red no. 40 fd&c yellow no. 6 glycerin menthol, unspecified form propylene glycol water sodium benzoate anhydrous citric acid saccharin sodium sorbitol guaifenesin guaifenesin codeine phosphate codeine anhydrous
Indications and Usage:
Uses temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
Warnings:
Warnings do not use in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor. ask a doctor before use if you have a cough with too much phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (maois). these combinations may cause greater sedation (drowsiness) than is caused by the product used alone. stop use and ask a doctor if cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. these can be signs of a serious condition. may cause or aggravate constipation if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of accidental overdose, seek professional assistance or contact a poison control cen
Read more...ter immediately. use of codeine-containing preparation is not recommended for children under 2 years of age.
Do Not Use:
Warnings do not use in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor. ask a doctor before use if you have a cough with too much phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (maois). these combinations may cause greater sedation (drowsiness) than is caused by the product used alone. stop use and ask a doctor if cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. these can be signs of a serious condition. may cause or aggravate constipation if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of accidental overdose, seek professional assistance or contact a poison control center immediately. use of codeine-containing preparation is not recommended for children under 2 years of age.
Dosage and Administration:
Directions take every 4 hours do not exceed 6 doses in 24 hours a special measuring device should be used to give an accurate dose of this product to children under 6 years of age giving a higher dose than recommended by a doctor can result in serious side effects for a child adults and children 12 years and over 10 ml (2 teaspoonfuls) children 6 to under 12 years of age 5 ml (1 teaspoonful) children under 6 years of age consult a doctor
Stop Use:
Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. these can be signs of a serious condition. may cause or aggravate constipation
Package Label Principal Display Panel:
Principal display panel - 473 ml bottle label ndc 0121-0775-16 guaifenesin and codeine phosphate oral solution usp cv 100 mg/10 mg per 5 ml expectorant / cough suppressant alcohol free / sugar free each teaspoonful (5 ml) contains: guaifenesin, usp 100 mg codeine phosphate, usp 10 mg dispense in a tight, light-resistant container with a child-resistant closure. do not accept if seal around cap is broken or missing 16 fl oz (473 ml) pai pharmaceutical associates, inc. greenville, sc 29605 principal display panel - 473 ml bottle label
Principal display panel - 5 ml unit dose cup label delivers 5 ml ndc 0121-1775-05 g uaifenesin and c odeine p hosphate o ral s olution usp cv 100 mg/10 mg per 5 ml expectorant / cough suppressant alcohol free / sugar free package not child-resistant pharmaceutical associates, inc. greenville, sc 29605 see insert principal display panel - 10 ml unit dose cup label
Principal display panel - 10 ml unit dose cup label delivers 10 ml ndc 0121-1550-10 g uaifenesin and c odeine p hosphate o ral s olution usp cv 200 mg/20 mg per 10 ml expectorant / cough suppressant alcohol free / sugar free package not child-resistant pharmaceutical associates, inc. greenville, sc 29605 see insert principal display panel - 10 ml unit dose cup label - 1775
Further Questions:
Questions or comments? call 1-800-845-8210 or visit paipharma.com serious side effects associated with use of this product may be reported to this number.