Nighttime Childrens Multi Symptoms Cold And Cough Multi-symptom Relief
Chlorpheniramine Maleate And Dextromethorphan Hydrobromide
Wal-mart Stores,inc.
Human Otc Drug
NDC 49035-545Nighttime Childrens Multi Symptoms Cold And Cough Multi-symptom Relief also known as Chlorpheniramine Maleate And Dextromethorphan Hydrobromide is a human otc drug labeled by 'Wal-mart Stores,inc.'. National Drug Code (NDC) number for Nighttime Childrens Multi Symptoms Cold And Cough Multi-symptom Relief is 49035-545. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Nighttime Childrens Multi Symptoms Cold And Cough Multi-symptom Relief drug includes Chlorpheniramine Maleate - 2 mg/15mL Dextromethorphan Hydrobromide - 15 mg/15mL . The currest status of Nighttime Childrens Multi Symptoms Cold And Cough Multi-symptom Relief drug is Active.
Drug Information:
| Drug NDC: | 49035-545 |
| 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: | Nighttime Childrens Multi Symptoms Cold And Cough Multi-symptom Relief |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Nighttime Childrens Multi Symptoms |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Cold and Cough Multi-Symptom Relief |
| 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: | Chlorpheniramine Maleate And Dextromethorphan Hydrobromide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Wal-mart Stores,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: | CHLORPHENIRAMINE MALEATE - 2 mg/15mL
DEXTROMETHORPHAN HYDROBROMIDE - 15 mg/15mL
|
| 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: | 30 Mar, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 03 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: | WAL-MART STORES,INC.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1114361
|
| 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: | V1Q0O9OJ9Z
9D2RTI9KYH
|
| 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 |
|---|
| 49035-545-08 | 236 mL in 1 BOTTLE, PLASTIC (49035-545-08) | 30 Mar, 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:
Active ingredients (in each 15 ml) purpose chlorpheniramine maleate 2 mg antihistamine dextromethorphan hbr 15 mg cough suppressant
Product Elements:
Nighttime childrens multi symptoms cold and cough multi-symptom relief chlorpheniramine maleate and dextromethorphan hydrobromide chlorpheniramine maleate chlorpheniramine dextromethorphan hydrobromide dextromethorphan anhydrous citric acid fd&c red no. 40 potassium citrate potassium sorbate propylene glycol water sodium benzoate sorbitol sucralose natural cherry flavor
Indications and Usage:
Uses temporarily relieves cold symptoms: ⪠cough due to minor throat & bronchial irritation ⪠sneezing ⪠runny nose
Warnings:
Warnings do not use ⪠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. ⪠to make a child sleep ask a doctor before use if you have ⪠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 ⪠trouble urinating due to enlarged prostate gland ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. when using this product ⪠excitability may occur, especially in children ⪠marked drowsiness may occur ⪠avoid alcoholic drinks ⪠be careful when driving a motor vehicle or operating machinery ⪠alcohol, sedatives, & tranqu
Read more...ilizers may increase drowsiness stop use and ask a doctor if ⢠cough persists more than 1 week, tends to recur 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 at 1-800-222-1222.
Do Not Use:
Warnings do not use ⪠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. ⪠to make a child sleep ask a doctor before use if you have ⪠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 ⪠trouble urinating due to enlarged prostate gland ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. when using this product ⪠excitability may occur, especially in children ⪠marked drowsiness may occur ⪠avoid alcoholic drinks ⪠be careful when driving a motor vehicle or operating machinery ⪠alcohol, sedatives, & tranquilizers may increase drowsiness stop use and ask a doctor if ⢠cough persists more than 1 week, tends to recur 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 at 1-800-222-1222.
When Using:
When using this product ⪠excitability may occur, especially in children ⪠marked drowsiness may occur ⪠avoid alcoholic drinks ⪠be careful when driving a motor vehicle or operating machinery ⪠alcohol, sedatives, & tranquilizers may increase drowsiness
Dosage and Administration:
Directions ⢠take only as directed ⢠do not exceed 4 doses per 24 hrs. ⢠only use the dose cup provided adults & children 12 yrs & over 30 ml every 6 hrs. children 6 to under 12 yrs 15 ml every 6 hrs. children 4 to under 6 yrs do not use unless directed by a doctor children under 4 yrs do not use
Stop Use:
Stop use and ask a doctor if ⢠cough persists more than 1 week, tends to recur 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 - 236 ml bottle label compare to childrenâs vicks nyquil⢠active ingredients* equate⢠ndc 49035-545-08 childrens sugar-free multi-symptoms cold & cough nighttime chlorpheniramine maleate 2 mg, dextromethorphan hbr 15 mg ⢠sneezing ⢠runny nose ⢠cough aspirin-free acetaminophen-free natural cherry flavor free of alcohol & acetaminophen 8 fl oz (236 ml) distributed by: walmart inc., bentonville, ar 72716 made in the usa with domestic and imported ingredients factory certified tamper evident: do not use if printed shrink band is missing or broken. *this product is manufactured or distributed by procter & gamble, the distributor of childrenâs vicks ® nyquil⢠satisfaction guaranteed â or weâll replace it or give you your money back. for questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915 walmart nighttime children's multi symptom cold and cough
Further Questions:
Questions or comments? 1-888-287-1915