Daytime And Nighttime Cough And Chest Congestion Childrens
Dextromethorphan Hbr, Guaifenesin, Chlorpheniramine Maleate
Cvs Pharmacy
Human Otc Drug
NDC 69842-657Daytime And Nighttime Cough And Chest Congestion Childrens also known as Dextromethorphan Hbr, Guaifenesin, Chlorpheniramine Maleate is a human otc drug labeled by 'Cvs Pharmacy'. National Drug Code (NDC) number for Daytime And Nighttime Cough And Chest Congestion Childrens is 69842-657. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Daytime And Nighttime Cough And Chest Congestion Childrens drug includes . The currest status of Daytime And Nighttime Cough And Chest Congestion Childrens drug is Active.
Drug Information:
| Drug NDC: | 69842-657 |
| 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: | Daytime And Nighttime Cough And Chest Congestion Childrens |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Daytime And Nighttime Cough And Chest Congestion |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Childrens |
| 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: | Dextromethorphan Hbr, Guaifenesin, Chlorpheniramine Maleate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Cvs Pharmacy |
| 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: | 19 Feb, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 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: | CVS Pharmacy
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1020138
1111440
2119625
|
| 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: | 0050428548080
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 69842-657-08 | 1 KIT in 1 KIT (69842-657-08) * 118 mL in 1 BOTTLE * 118 mL in 1 BOTTLE | 19 Feb, 2019 | 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 for day time cough suppressant expectorant
Purpose for night time antihistamine cough suppressant
Product Elements:
Daytime and nighttime cough and chest congestion childrens dextromethorphan hbr, guaifenesin, chlorpheniramine maleate daytime cough and chest congestion grape flavor dextromethorphan hbr, guaifenesin dextromethorphan hydrobromide dextromethorphan guaifenesin guaifenesin anhydrous citric acid edetate disodium fd&c blue no. 1 fd&c red no. 40 potassium citrate propylene glycol water sodium benzoate sorbitol sucralose xanthan gum night time cough dm fruit punch chlorpheniramine maleate, diphenhydramine hbr chlorpheniramine maleate chlorpheniramine dextromethorphan hydrobromide dextromethorphan anhydrous citric acid fd&c red no. 40 potassium sorbate potassium citrate propylene glycol water sodium benzoate sorbitol sucralose
Indications and Usage:
Uses daytime ⢠temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold ⢠helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes nighttime ⢠temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold ⢠temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ⢠runny nose ⢠sneezing ⢠itching of the nose or throat ⢠itchy, watery eyes
Warnings:
Warnings do not us daytime ⢠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. nighttime ⢠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 daytime ⢠cough that occurs with too much phlegm (mucus) ⢠cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema nighttime ⢠trouble urinating du
Read more...e to an enlarges prostate gland ⢠glaucoma ⢠a 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 nighttime taking sedatives or tranquilizers. when using this product nighttime ⢠do not use more than directed. ⢠marked drowsiness may occur ⢠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 daytime ⢠cough last more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. these could be signs of a serious condition. nighttime ⢠cough last 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, daytime ask a health professional before use. nighttime ask a health professional before use keep out of reach of children. daytime in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away. nighttime in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away
Do Not Use:
Warnings do not us daytime ⢠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. nighttime ⢠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 daytime ⢠cough that occurs with too much phlegm (mucus) ⢠cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema nighttime ⢠trouble urinating due to an enlarges prostate gland ⢠glaucoma ⢠a 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 nighttime taking sedatives or tranquilizers. when using this product nighttime ⢠do not use more than directed. ⢠marked drowsiness may occur ⢠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 daytime ⢠cough last more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. these could be signs of a serious condition. nighttime ⢠cough last 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, daytime ask a health professional before use. nighttime ask a health professional before use keep out of reach of children. daytime in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away. nighttime in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away
When Using:
When using this product nighttime ⢠do not use more than directed. ⢠marked drowsiness may occur ⢠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 daytime ⢠measure only with dosing cup provided. ⢠keep dosing cup with product ⢠ml= milliliter ⢠do not take more than 6 doses in any 24-hour period age dose children under 4 years do not use children 4 to under 6 years 5 ml every 4 hours children 6 to under 12 years 10 ml every 4 hours adults and children 12 years and older 20 ml every 4 hours nighttime ⢠measure only with dosing cup provided. ⢠keep dosing cup with product ⢠ml= milliliter ⢠do not take more than 4 doses in any 24-hour period age dose children under 6 years do not use children 6 to under 12 years 10 ml every 6 hours adults and children 12 years and older 20 ml every 6 hours
Stop Use:
Stop use and ask a doctor if daytime ⢠cough last more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. these could be signs of a serious condition. nighttime ⢠cough last 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, daytime ask a health professional before use. nighttime ask a health professional before use
Package Label Principal Display Panel:
Principal display panel compare to the active ingredients in children's robitussin ® cough & chest congestion dm* non-drowsy children's cough & chest congestions dm each 5 ml dose of oral solution contains: dextromethorphan hbr, usp 5 mg cough suppressant guaifenesin, usp 100 mg expectorant relieves ⢠chest congestion/mucus ⢠cough for ages 4 and over grape flavor naturally and artificially flavored dosage cup included two 4 fl oz (118 ml) bottles total â 8 fl oz (236 ml) compare to the active ingredients in children's robitussin ® nighttime cough dm* ndc# 69842-657-08 children's nighttime cough dm each 10 ml dose of oral solution contains: chlorpheniramine maleate, usp 2 mg antihistamine dextromethorphan hbr, usp 15 mg cough suppressant relieves ⢠cough up to 8 hours ⢠runny nose alcohol free for ages 6 & over fruit punch flavor naturally and artificially flavored dosage cup included two 4 fl oz (118 ml) bottles total â 8 fl oz (236 ml) * this product is not manufactured or distributed by pfizer, owner of the registered trademarks childrenâs robitussin ® cough + chest congestion dm and childrenâs robitussin ® nighttime cough dm. distributed by: cvs pharmacy, inc. one cvs drive, woonsocket, ri 02895 ©2018 cvs/pharmacy cvs.com ® 1-800-shop cvs v-12431 cvs ® quality money back guarantee cvs health children's daytime & nighttime cough & chest congestion dm
Further Questions:
Questions or comments? 1-866-467-2748