Daytime Cold And Cough And Nighttime Cold And Congestion Childrens
Brompheniramine Maleate, Dextromethorphan Hbr, Phenylephrine Hcl, Diphenhydramine Hcl, Phenylephrine Hcl
Walgreens
Human Otc Drug
NDC 0363-4590Daytime Cold And Cough And Nighttime Cold And Congestion Childrens also known as Brompheniramine Maleate, Dextromethorphan Hbr, Phenylephrine Hcl, Diphenhydramine Hcl, Phenylephrine Hcl is a human otc drug labeled by 'Walgreens'. National Drug Code (NDC) number for Daytime Cold And Cough And Nighttime Cold And Congestion Childrens is 0363-4590. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Daytime Cold And Cough And Nighttime Cold And Congestion Childrens drug includes . The currest status of Daytime Cold And Cough And Nighttime Cold And Congestion Childrens drug is Active.
Drug Information:
| Drug NDC: | 0363-4590 |
| 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 Cold And Cough And Nighttime Cold And Congestion Childrens |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Daytime Cold And Cough And Nighttime Cold And 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: | Brompheniramine Maleate, Dextromethorphan Hbr, Phenylephrine Hcl, Diphenhydramine Hcl, Phenylephrine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Walgreens |
| 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: | 04 Mar, 2022 |
| 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: | Walgreens
|
| 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. |
| UPC: | 0311917176796
|
| 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 |
|---|
| 0363-4590-08 | 1 KIT in 1 KIT (0363-4590-08) * 118 mL in 1 BOTTLE, PLASTIC * 118 mL in 1 BOTTLE, PLASTIC | 04 Mar, 2022 | 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:
Purpose for nighttime antihistamine / cough suppressant nasal decongestant
Purpose for daytime antihistamine cough suppressant nasal decongestant
Product Elements:
Daytime cold and cough and nighttime cold and congestion childrens brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl, diphenhydramine hcl, phenylephrine hcl night time cold and congestion childrens diphenhydramine hcl, phenylephrine hcl diphenhydramine hydrochloride diphenhydramine phenylephrine hydrochloride phenylephrine fd&c blue no. 1 propylene glycol water fd&c red no. 40 acesulfame potassium anhydrous citric acid edetate disodium maltitol sodium benzoate trisodium citrate dihydrate daytime cold and cough childrens brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl brompheniramine maleate brompheniramine dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine glycerin propylene glycol water sorbitol anhydrous citric acid fd&c blue no. 1 fd&c red no. 40 sodium benzoate sucralose trisodium citrate dihydrate
Indications and Usage:
Uses nighttime temporarily relieves these symptoms occuring with a cold, hay fever, or other upper respiratory allergies nasal congestion cough runny nose sneezing itchy, watery eyes itching of the nose or throat daytime temporaily relieves cough due to minor throat and bronchial irritation occuring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves these symptoms due to hay fever (allergic rhinitis) runny nose itchy, watery eyes sneezing itching of the nose or throat temporarily restores freer breathing through the nose
Warnings:
Warnings do not use 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 parkinsonâs 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. daytime to sedate a child or to make sleepy if you are now taking a prescription monoamine oxidase inhibitor (maoi)(certain drugs for depression,psychiatic 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 nighttime heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged
Read more... prostate gland cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that last as occurs with smoking,asthma, chronic bronchitis or emphysema daytime heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged gland cough that occurs with too much phlegm (mucus) a breathing problem or persistent 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 nighttime taking any other oral nasal decongestant or stimulant taking sedative or tranquilizers daytime taking any other oral nasal decongestant or stimulant taking sedative or tranquilizers when using these products 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 excitablity may occur, especially in children daytime do not use more than directed marked drowsiness may occur avoid alcoholic drinks alcohol, sedative 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 nighttime you get nervous, dizzy or sleepless symptoms do not get better within 7 days or occur with a 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 daytime nervousness, dizziness or sleeplessness occur symptoms do not improve 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, nighttime ask a health professional before use. daytime ask a health professional before use keep out of reach of children. nighttime in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away. daytime 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 use 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 parkinsonâs 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. daytime to sedate a child or to make sleepy if you are now taking a prescription monoamine oxidase inhibitor (maoi)(certain drugs for depression,psychiatic 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 nighttime heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that last as occurs with smoking,asthma, chronic bronchitis or emphysema daytime heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged gland cough that occurs with too much phlegm (mucus) a breathing problem or persistent 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 nighttime taking any other oral nasal decongestant or stimulant taking sedative or tranquilizers daytime taking any other oral nasal decongestant or stimulant taking sedative or tranquilizers when using these products 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 excitablity may occur, especially in children daytime do not use more than directed marked drowsiness may occur avoid alcoholic drinks alcohol, sedative 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 nighttime you get nervous, dizzy or sleepless symptoms do not get better within 7 days or occur with a 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 daytime nervousness, dizziness or sleeplessness occur symptoms do not improve 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, nighttime ask a health professional before use. daytime ask a health professional before use keep out of reach of children. nighttime in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away. daytime in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away.
When Using:
When using these products 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 excitablity may occur, especially in children daytime do not use more than directed marked drowsiness may occur avoid alcoholic drinks alcohol, sedative 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 nighttime do not take more than 6 doses in any 24 hours period do not exceed recommended dosage measure only with dosing cup provided. do not use any other dosing device keep dosing cup with product ml = mililiter age dose adults and children 12 years and over 20 ml every 4 hours childen 6 to under 12 years 10 ml every 4 hours children under 6 years do not use daytime do not take more than 6 doses in any 24 hours period measure only with dosing cup provided. do not use any other dosing dosing device. keep dosing cup with product ml = mililiter age dose adults and children12 years and over 20 ml every 4 hours children 6 to under 11 years 10 ml every 4 hours children under 6 years do not use
Stop Use:
Stop use and ask a doctor if nighttime you get nervous, dizzy or sleepless symptoms do not get better within 7 days or occur with a 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 daytime nervousness, dizziness or sleeplessness occur symptoms do not improve 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 compare to the active ingredients in children's dimetapp® cold & cough & nighttime cold & congestionâ â children's cold & congestion relief diphenhydramine hcl 12.5 mg / anrihistamine / cough suppressant phenylephrine hcl 5 mg / nasal decongestant nighttime alcohol free relieves stuffy nose, runny nose, sneezing, itchy & watery eyes & coughing ages 6 years & older grape flavor dosing cup included ages 6 + years tamper evident: do not use if carton is opened or if printed safety seal around bottle or under cap is broken or missing. â â this product is not manufactured or distributed by pfizer consumer healthcare, distributor of children's dimetapp® nighttime cold & congestion. daytime children's cold & cough relief brompheniramine maleate 2 mg antihistamine dextromethorphan hbr 10 mg / cough suppressant phenylephrine hci 5 mg / nasal decongestant daytime alcohol free relieves nasal congestion, runny nose, itchy & watery eyes, sneezing & coughing ages 6 years & older grape flavor fl oz (ml) â â this product is not manufactured or distributed by pfizer consumer healthcare, distributor of children's dimetapp® cold & cough. distributed by: walgreen co. 200 wilmot rd., deerfield, il 60015
Product label walgreens children's cold & congestion relief, children's cold & cough relief diphenhydramine hcl 12.5 mg, phenylephrine hcl 5 mg, brompheniramine maleate 2 mg, dextromethorphan hbr 10 mg, phenylephrine hcl 5 mg
Further Questions:
Questions or comments? call 1 -877-753-3935 monday-friday 9am-5pm est