Dimetapp Nighttime Cold And Congestion
Diphenhydramine Hydrochloride And Phenylephrine Hydrochloride
Foundation Consumer Brands
Human Otc Drug
NDC 80070-340Dimetapp Nighttime Cold And Congestion also known as Diphenhydramine Hydrochloride And Phenylephrine Hydrochloride is a human otc drug labeled by 'Foundation Consumer Brands'. National Drug Code (NDC) number for Dimetapp Nighttime Cold And Congestion is 80070-340. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Dimetapp Nighttime Cold And Congestion drug includes Diphenhydramine Hydrochloride - 6.25 mg/5mL Phenylephrine Hydrochloride - 2.5 mg/5mL . The currest status of Dimetapp Nighttime Cold And Congestion drug is Active.
Drug Information:
| Drug NDC: | 80070-340 |
| 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: | Dimetapp Nighttime Cold And Congestion |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Dimetapp |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Nighttime Cold and Congestion |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Diphenhydramine Hydrochloride And Phenylephrine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Foundation Consumer Brands |
| 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: | DIPHENHYDRAMINE HYDROCHLORIDE - 6.25 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE - 2.5 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: | 15 Sep, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Dec, 2025 |
| 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: | Foundation Consumer Brands
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1236048
|
| 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. |
| UPC: | 0850026660043
|
| UPC stands for Universal Product Code. |
| UNII: | TC2D6JAD40
04JA59TNSJ
|
| 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: | Adrenergic alpha1-Agonists [MoA]
Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [EPC]
alpha-1 Adrenergic Agonist [EPC]
|
| 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 |
|---|
| 80070-340-04 | 1 BOTTLE in 1 CARTON (80070-340-04) / 118 mL in 1 BOTTLE | 15 Sep, 2021 | 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 10 ml) purposes diphenhydramine hcl, 12.5 mg antihistamine/cough suppressant phenylephrine hcl, 5 mg nasal decongestant
Product Elements:
Dimetapp nighttime cold and congestion diphenhydramine hydrochloride and phenylephrine hydrochloride diphenhydramine hydrochloride diphenhydramine phenylephrine hydrochloride phenylephrine anhydrous citric acid fd&c blue no. 1 fd&c red no. 40 glycerin propyl gallate propylene glycol water sodium benzoate sodium citrate, unspecified form sorbitol sucralose
Indications and Usage:
Uses temporarily relieves: nasal congestion runny nose cough sneezing itching of the nose or throat itchy, watery eyes due to hay fever temporarily restores freer breathing through the nose
Warnings:
Warnings do not use to sedate a child or to make a child sleepy 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. with any other product containing diphenhydramine, even one used on skin ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant taking sedatives or tranquilizers when using this product do not use more than directed may cause marked drowsin
Read more...ess 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 children stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs symptoms do not get better within 7 days or are accompanied by fever 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. 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.
Do Not Use:
Warnings do not use to sedate a child or to make a child sleepy 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. with any other product containing diphenhydramine, even one used on skin ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant taking sedatives or tranquilizers when using this product do not use more than directed may cause marked drowsiness 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 children stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs symptoms do not get better within 7 days or are accompanied by fever 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. 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.
When Using:
When using this product do not use more than directed may cause marked drowsiness 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 children
Dosage and Administration:
Directions do not take more than 6 doses in any 24-hour period measure only with dosage cup provided keep dosage cup with product ml = milliliter age dose adults and children 12 years and over 20 ml every 4 hours children 6 to under 12 years 10 ml every 4 hours children under 6 years do not use
Stop Use:
Stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs symptoms do not get better within 7 days or are accompanied by fever 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.
Package Label Principal Display Panel:
Principal display panel - 118 ml bottle carton children's dimetapp ® diphenhydramine hcl (antihistamine/cough suppressant) phenylephrine hcl (nasal decongestant) pharmacist recommended nighttime cold & congestion relieves + comforts: â stuffy, runny nose â itchy, watery eyes â sneezing â cough 6+ yrs 4 fl oz (118 ml) grape flavor ⢠alcohol free principal display panel - 118 ml bottle carton
Further Questions:
Questions or comments? call 1-888-594-0828 weekdays 9 am to 5 pm est