Careone Triacting Night Time Cold And Cough Childrens
Diphenhydramine Hcl, Phenylephrine Hcl
American Sales Company
Human Otc Drug
NDC 41520-913Careone Triacting Night Time Cold And Cough Childrens also known as Diphenhydramine Hcl, Phenylephrine Hcl is a human otc drug labeled by 'American Sales Company'. National Drug Code (NDC) number for Careone Triacting Night Time Cold And Cough Childrens is 41520-913. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Careone Triacting Night Time Cold And Cough Childrens drug includes Diphenhydramine Hydrochloride - 6.25 mg/5mL Phenylephrine Hydrochloride - 2.5 mg/5mL . The currest status of Careone Triacting Night Time Cold And Cough Childrens drug is Active.
Drug Information:
| Drug NDC: | 41520-913 |
| 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: | Careone Triacting Night Time Cold And Cough Childrens |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Careone Triacting Night Time Cold And Cough |
| 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: | Diphenhydramine Hcl, Phenylephrine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | American Sales Company |
| 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: | DIPHENHYDRAMINE HYDROCHLORIDE - 6.25 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE - 2.5 mg/5mL
|
| 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: | 05 Jun, 2009 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 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: | American Sales Company
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1236048
|
| 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: | TC2D6JAD40
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]
Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [EPC]
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 |
|---|
| 41520-913-26 | 1 BOTTLE in 1 CARTON (41520-913-26) / 118 mL in 1 BOTTLE | 05 Jun, 2009 | 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/cough suppressant nasal decongestant
Product Elements:
Careone triacting night time cold and cough childrens diphenhydramine hcl, phenylephrine hcl phenylephrine hydrochloride phenylephrine diphenhydramine hydrochloride diphenhydramine acesulfame potassium anhydrous citric acid edetate disodium fd&c blue no. 1 fd&c red no. 40 propylene glycol water sodium benzoate sodium citrate
Indications and Usage:
Uses temporarily relieves: sneezing itchy nose or throat runny nose itchy, watery eyes due to hay fever nasal and sinus congestion cough due to minor throat and bronchial irritation as may occur with a cold
Warnings:
Warnings do not use in a child under 4 years of age in a child who is taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinsons disease), or for 2 weeks after stopping the maoi drug. if you do not know if your childs prescription drug contains an maoi, ask a doctor or pharmacist before giving this product. with any other product containing diphenhydramine, even one used on skin to make a child sleepy ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes glaucoma cough that occurs with too much phlegm (mucus) chronic cough that lasts or as occurs with asthma a breathing problem such as chronic bronchitis ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers when using this product do not exceed recommended dosage may cause marked drowsiness sedatives and tranquilizers may increas
Read more...e drowsiness excitability may occur, especially in children stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs symptoms do not improve within 7 days or occur with fever cough persists for more than 7 days, comes back, or occurs with fever, rash or persistent headache. a persistent cough may be a sign of a serious condition. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222).
Do Not Use:
Warnings do not use in a child under 4 years of age in a child who is taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinsons disease), or for 2 weeks after stopping the maoi drug. if you do not know if your childs prescription drug contains an maoi, ask a doctor or pharmacist before giving this product. with any other product containing diphenhydramine, even one used on skin to make a child sleepy ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes glaucoma cough that occurs with too much phlegm (mucus) chronic cough that lasts or as occurs with asthma a breathing problem such as chronic bronchitis ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers when using this product do not exceed recommended dosage may cause marked drowsiness sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs symptoms do not improve within 7 days or occur with fever cough persists for more than 7 days, comes back, or occurs with fever, rash or persistent headache. a persistent cough may be a sign of a serious condition. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222).
When Using:
When using this product do not exceed recommended dosage may cause marked drowsiness sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children
Dosage and Administration:
Directions may be given every 4 hours. do not give more than 6 doses in 24 hours unless directed by a doctor. use enclosed dosing cup only. keep for use with this product only. do not use any other dosing device. age dose children under 4 years of age do not use children 4 to under 6 years of age do not use unless directed by a doctor children 6 to under 12 years of age 10 ml
Stop Use:
Stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs symptoms do not improve within 7 days or occur with fever cough persists for more than 7 days, comes back, or occurs with fever, rash or persistent headache. a persistent cough may be a sign of a serious condition.
Package Label Principal Display Panel:
Principal display panel compare to the active ingredients in childrens triaminic® night time cold & cough for ages 6 to 12 years childrens triacting nighttime cold & cough antihistamine/cough suppressant diphenhydramine hcl 6.25 mg nasal decongestant phenylephrine hcl 2.5 mg relieves: cough runny, stuffy nose itchy throat gluten free grape flavor our pharmacists recommend 4 fl oz (118 ml) 913-26-cold & cough.jpg
Further Questions:
Questions or comments? 1-800-719-9260