Dimetapp Cold And Cough And Dimetapp Nighttime Cold And Congestion

Brophiramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, And Diphenhydramine Hyrdochloride

Foundation Consumer Brands
Human Otc Drug
NDC 80070-360

Dimetapp Cold And Cough And Dimetapp Nighttime Cold And Congestion also known as Brophiramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, And Diphenhydramine Hyrdochloride is a human otc drug labeled by 'Foundation Consumer Brands'. National Drug Code (NDC) number for Dimetapp Cold And Cough And Dimetapp Nighttime Cold And Congestion is 80070-360. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Dimetapp Cold And Cough And Dimetapp Nighttime Cold And Congestion drug includes . The currest status of Dimetapp Cold And Cough And Dimetapp Nighttime Cold And Congestion drug is Active.

Drug Information:

Drug NDC:	80070-360
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 Cold And Cough And Dimetapp Nighttime Cold And Congestion
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:	Brophiramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, And Diphenhydramine Hyrdochloride
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:	Kit
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:
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:
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:	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:	Foundation Consumer Brands
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1090463 1236048 1666116
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:
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.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
80070-360-12	1 KIT in 1 CARTON (80070-360-12) * 1 BOTTLE in 1 CARTON (80070-310-04) / 118 mL in 1 BOTTLE * 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.

Other medicines with the same generic name

Dimetapp Cold And Cough And Dimetapp Nighttime Cold And Congestion

Brophiramine Maleate & more..

Kit
Foundation Consumer Brands
NDC: 80070-360

Purpose:

Active ingredients (in each 10 ml) purposes brompheniramine maleate, 2 mg antihistamine dextromethorphan hbr, 10 mg cough suppressant phenylephrine hcl, 5 mg nasal decongestant

Active ingredients (in each 10 ml) purposes diphenhydramine hcl, 12.5 mg antihistamine/cough suppressant phenylephrine hcl, 5 mg nasal decongestant

Product Elements:

Dimetapp cold and cough and dimetapp nighttime cold and congestion brophiramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride, and diphenhydramine hyrdochloride dimetapp cold and cough brompheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride brompheniramine maleate brompheniramine dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine anhydrous citric acid fd&c blue no. 1 fd&c red no. 40 glycerin propylene glycol water sodium benzoate sodium citrate, unspecified form sorbitol sucralose 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:

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.

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. 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 such 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 beverages 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.

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 beverages alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children

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.

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 - kit carton daytime nighttime children's dimetapp Â® cold & cough brompheniramine maleate (antihistamine) dextromethorphan hbr (cough suppressant) phenylephrine hcl (nasal decongestant) relieves + comforts: â stuffy, runny nose â itchy, watery eyes â sneezing â cough grape flavor alcohol free 6+ yrs 2 bottles pharmacist recommended 4 fl oz (118 ml) each nighttime cold & congestion diphenhydramine hcl (antihistamine/cough suppressant) phenylephrine hcl (nasal decongestant) relieves + comforts: â stuffy, runny nose â itchy, watery eyes â sneezing â cough 6+ yrs grape flavor alcohol free 1 bottle 4 fl oz (118 ml) 12 fl oz (354 ml) total principal display panel - kit carton

Further Questions:

Questions or comments? call 1-888-594-0828 weekdays 9 am to 5 pm est

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.