Cold And Allergy Relief
Chlorpheniramine Maleate, Phenylephrine Hcl
H E B
Human Otc Drug
NDC 37808-890Cold And Allergy Relief also known as Chlorpheniramine Maleate, Phenylephrine Hcl is a human otc drug labeled by 'H E B'. National Drug Code (NDC) number for Cold And Allergy Relief is 37808-890. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Cold And Allergy Relief drug includes Chlorpheniramine Maleate - 4 mg/1 Phenylephrine Hydrochloride - 10 mg/1 . The currest status of Cold And Allergy Relief drug is Active.
Drug Information:
| Drug NDC: | 37808-890 |
| 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: | Cold And Allergy Relief |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| 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, Phenylephrine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | H E B |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| 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 - 4 mg/1
PHENYLEPHRINE HYDROCHLORIDE - 10 mg/1
|
| 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 Aug, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Aug, 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: | 03 May, 2026 |
| 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: | H E B
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1090443
|
| 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: | 0041220384129
|
| UPC stands for Universal Product Code. |
| UNII: | V1Q0O9OJ9Z
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 |
|---|
| 37808-890-24 | 24 BLISTER PACK in 1 CARTON (37808-890-24) / 1 TABLET in 1 BLISTER PACK | 31 Aug, 2016 | 31 Aug, 2025 | 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 antihistamine nasal decongestant
Product Elements:
Cold and allergy relief chlorpheniramine maleate, phenylephrine hcl chlorpheniramine maleate chlorpheniramine phenylephrine hydrochloride phenylephrine silicon dioxide calcium phosphate, dibasic, anhydrous hypromelloses magnesium stearate cellulose, microcrystalline mineral oil starch, corn sodium starch glycolate type a corn stearic acid t127
Indications and Usage:
Uses temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing nasal congestion itching of the nose or throat itchy, watery eyes temporarily relieves these symptoms due to the common cold: runny nose sneezing nasal congestion
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 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. ask a doctor before use if you have high blood pressure heart disease thyroid disease diabetes glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. when using this product do not use more than directed excitability may occur, especially in children drowsiness may occur avoid alcoholic drinks alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if nervousness, dizziness, r sleeplessness occur sym
Read more...ptoms do not improve within 7 days or occur with a fever if pregnant or breast-feeding, ask a health care professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
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 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. ask a doctor before use if you have high blood pressure heart disease thyroid disease diabetes glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. when using this product do not use more than directed excitability may occur, especially in children drowsiness may occur avoid alcoholic drinks alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if nervousness, dizziness, r sleeplessness occur symptoms do not improve within 7 days or occur with a fever if pregnant or breast-feeding, ask a health care professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
When Using:
When using this product do not use more than directed excitability may occur, especially in children drowsiness may occur avoid alcoholic drinks alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery
Dosage and Administration:
Directions take every 4 hours do not take more than 6 doses in 24 hours adults and children 12 years of age and older take 1 tablet children 6 to under 12 years of age take 1/2 tablet children under 6 years of age consult a doctor children under 4 years of age do not use
Stop Use:
Stop use and ask a doctor if nervousness, dizziness, r sleeplessness occur symptoms do not improve within 7 days or occur with a fever
Package Label Principal Display Panel:
Principal display panel compare to actifed® cold & allergy active ingredients** maximum strength cold & allergy relief chlorpheniramine maleate 4 mg / antihistamine phenylephrine hcl 10 mg / nasal decongestant allergy & congestion relief of: nasal congestion runny nose sneezing itchy, watery eyes for ages 6 years and older does not contain pseudoephedrine tablets *this product is not manufactured or distributed by mcneil consumer healthcare, distributor of actifed® cold & allergy. tamper evident: do not use if carton is opened or if blister unit is torn, broken or shows any signs of tampering. keep outer carton for complete warnings and product information. made with pride and care for h-e-b®, san antonio, tx 78204
Product label h-e-b cold & allergy relief chlorpheniramine maleate 4 mg, phenylephrine hci 10 mg
Further Questions:
Questions or comments? call toll free: 1-877-753-3935 monday-friday 9am-5pm est