Diabetic Tussin Nighttime Cold And Flu
Acetaminophen, Dextromethorphan Hbr, And Diphenhydramine Hcl
Medtech Products Inc
Human Otc Drug
NDC 61787-516Diabetic Tussin Nighttime Cold And Flu also known as Acetaminophen, Dextromethorphan Hbr, And Diphenhydramine Hcl is a human otc drug labeled by 'Medtech Products Inc'. National Drug Code (NDC) number for Diabetic Tussin Nighttime Cold And Flu is 61787-516. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Diabetic Tussin Nighttime Cold And Flu drug includes Acetaminophen - 650 mg/10mL Dextromethorphan Hydrobromide - 20 mg/10mL Diphenhydramine Hydrochloride - 25 mg/10mL . The currest status of Diabetic Tussin Nighttime Cold And Flu drug is Active.
Drug Information:
| Drug NDC: | 61787-516 |
| 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: | Diabetic Tussin Nighttime Cold And Flu |
| 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: | Acetaminophen, Dextromethorphan Hbr, And Diphenhydramine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Medtech Products Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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: | ACETAMINOPHEN - 650 mg/10mL
DEXTROMETHORPHAN HYDROBROMIDE - 20 mg/10mL
DIPHENHYDRAMINE HYDROCHLORIDE - 25 mg/10mL
|
| 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 Feb, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 Jun, 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: | MEDTECH PRODUCTS INC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1094131
|
| 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. |
| UNII: | 362O9ITL9D
9D2RTI9KYH
TC2D6JAD40
|
| 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: | Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [EPC]
Sigma-1 Agonist [EPC]
Sigma-1 Receptor Agonists [MoA]
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]
Uncompetitive NMDA Receptor Antagonists [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 61787-516-04 | 1 BOTTLE in 1 CARTON (61787-516-04) / 118 mL in 1 BOTTLE | 01 Feb, 2020 | 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:
Purposes pain relief cough suppressant antihistamine
Product Elements:
Diabetic tussin nighttime cold and flu acetaminophen, dextromethorphan hbr, and diphenhydramine hcl acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan diphenhydramine hydrochloride diphenhydramine acesulfame potassium hypromellose, unspecified menthol, unspecified form methylparaben polyethylene glycol 400 potassium sorbate propylene glycol raspberry water anhydrous citric acid artificial raspberry flavor
Indications and Usage:
Uses temporarily relieves common cold/flu symptoms including: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains muscular aches fever runny nose and sneezing
Warnings:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if adults take more than 6 doses in 24 hours, which is the maximum daily amount child takes more than 5 doses in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks everyday while using this product sore throat warning: if sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use ask a doctor before use if you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to enlargement of the prostate gland cough that occurs with too much phlegm (mucus) a chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin, tranquilizers or sedatives.
Read more... when using this product: you may get very drowsy avoid alcoholic drinks alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in small children stop use and ask a doctor if redness or swelling is present fever gets worse or lasts more than 3 days new symptoms occur pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) cough comes back or occurs with rash or headache that lasts these could be signs of a serious condition. 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. prompt medical attention is critical even if you do not notice any signs or symptoms.
Do Not Use:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if adults take more than 6 doses in 24 hours, which is the maximum daily amount child takes more than 5 doses in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks everyday while using this product sore throat warning: if sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use ask a doctor before use if you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to enlargement of the prostate gland cough that occurs with too much phlegm (mucus) a chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin, tranquilizers or sedatives. when using this product: you may get very drowsy avoid alcoholic drinks alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in small children stop use and ask a doctor if redness or swelling is present fever gets worse or lasts more than 3 days new symptoms occur pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) cough comes back or occurs with rash or headache that lasts these could be signs of a serious condition. 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. prompt medical attention is critical even if you do not notice any signs or symptoms.
When Using:
When using this product: you may get very drowsy avoid alcoholic drinks alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in small children
Dosage and Administration:
Directions take every 4 to 6 hours do not exceed more than 6 doses in 24 hours for adults and children over 12 years of age adults 10 ml (2 teaspoons) children under 12 years ask a doctor
Stop Use:
Stop use and ask a doctor if redness or swelling is present fever gets worse or lasts more than 3 days new symptoms occur pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) cough comes back or occurs with rash or headache that lasts these could be signs of a serious condition.
Package Label Principal Display Panel:
Package/label principal display panel sugar & alcohol free! specifically formulated for diabetics diabetic tussin ® nighttime cold & flu acetaminophen (pain relief) dextromethorphan hbr (cough suppressant) diphenhydramine hcl (antihistamine) relieves: cough sore throat runny nose & sneezing minor aches & pains headache fever improved berry flavor 4 fl oz (118 ml) sugar & alcohol free! specifically formulated for diabetics diabetic tussin® nighttime cold & flu acetaminophen (pain relief) dextromethorphan hbr (cough suppressant) diphenhydramine hcl (antihistamine) relieves: ⢠cough ⢠sore throat ⢠runny nose & sneezing ⢠minor aches & pains ⢠headache ⢠fever improved berry flavor 4 fl oz (118 ml)
Further Questions:
Questions or comments? call: 1-800-579-8327 , serious side effects associated with use of this product may be reported to this number.