Childrens Wal Tap Elixer Cold And Allergy
Brompheniramine Maleate, Phenylephrine Hcl
Walgreens
Human Otc Drug
NDC 0363-0312Childrens Wal Tap Elixer Cold And Allergy also known as Brompheniramine Maleate, Phenylephrine Hcl is a human otc drug labeled by 'Walgreens'. National Drug Code (NDC) number for Childrens Wal Tap Elixer Cold And Allergy is 0363-0312. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Childrens Wal Tap Elixer Cold And Allergy drug includes Brompheniramine Maleate - 2 mg/10mL Phenylephrine Hydrochloride - 5 mg/10mL . The currest status of Childrens Wal Tap Elixer Cold And Allergy drug is Active.
Drug Information:
| Drug NDC: | 0363-0312 |
| 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: | Childrens Wal Tap Elixer Cold And Allergy |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Childrens Wal Tap Elixer |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Cold and Allergy |
| 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, 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: | Liquid |
| 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: | BROMPHENIRAMINE MALEATE - 2 mg/10mL
PHENYLEPHRINE HYDROCHLORIDE - 5 mg/10mL
|
| 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: | 31 Mar, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 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: | Walgreens
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1053258
|
| 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: | 0311917176789
|
| UPC stands for Universal Product Code. |
| UNII: | IXA7C9ZN03
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]
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 |
|---|
| 0363-0312-08 | 1 BOTTLE in 1 BOX (0363-0312-08) / 237 mL in 1 BOTTLE | 31 Mar, 2015 | 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 antihistamine nasal decongestant
Product Elements:
Childrens wal tap elixer cold and allergy brompheniramine maleate, phenylephrine hcl brompheniramine maleate brompheniramine phenylephrine hydrochloride phenylephrine fd&c blue no. 1 fd&c red no. 40 glycerin propylene glycol water sodium benzoate trisodium citrate dihydrate sorbitol sucralose anhydrous citric acid
Indications and Usage:
Uses temporarily relieves 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 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 glaucoma diabetes thyroid disease trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis 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 drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, espec
Read more...ially in children stop use and ask a doctor if nervousness, dizziness or sleeplessness occur symptoms do not get better within 7 days or are accompanied by fever 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 (1-800-222-1222) 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 glaucoma diabetes thyroid disease trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis 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 drowsiness may occur 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 occur symptoms do not get better within 7 days or are accompanied by fever 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 (1-800-222-1222) right away.
When Using:
When using this product do not use more than directed drowsiness may occur 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
Dosage and Administration:
Directions do not take more than 6 doses in any 24-hour period measure only with dosing cup provided. do not use any other dosing device. keep dosing cup with product ml = milliliter age dose adults and children 12 years and over 20 ml every 4 hours children 6 to 11 years 10 ml every 4 hours children under 6 years do not use
Package Label Principal Display Panel:
Principal display panel compare to the active ingredients in children's dimetapp® cold & allergy children's cold & allergy relief brompheniramide maleate 2 mg / antihistamine phenylephrine hci 5 mg / nasal decongestant alcohol free relieves itchy, watery eyes, runny nose, sneezing, stuffy nose & itching of the nose or throat ages 6 years & older grape flavor fl oz (ml) dosage cup provided this product is not manufactured or distributed by pfizer consumer healthcare, distributors of children's dimetapp® cold & allergy. tamper evident: do not use if carton is opened or if printed safety seal around bottle or under cap is broken or missing. distributed by : walgreen co 200 wilmot rd., deerfield, il 60015 walgreens.com
Package label walgreens children's cold & allergy relief grape flavor brompheniramine maleate 2 mg, phenylephrine hcl 5 mg
Further Questions:
Questions or comments? call 1-877-753-3935 monday-friday 9am-5pm est