Allergy Relief 4 Hour
Chlorpheniramine Maleate
Cardinal Health 110, Llc. Dba Leader
Human Otc Drug
NDC 70000-0160Allergy Relief 4 Hour also known as Chlorpheniramine Maleate is a human otc drug labeled by 'Cardinal Health 110, Llc. Dba Leader'. National Drug Code (NDC) number for Allergy Relief 4 Hour is 70000-0160. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Allergy Relief 4 Hour drug includes Chlorpheniramine Maleate - 4 mg/1 . The currest status of Allergy Relief 4 Hour drug is Active.
Drug Information:
| Drug NDC: | 70000-0160 |
| 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: | Allergy Relief 4 Hour |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Allergy Relief |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | 4 Hour |
| 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 |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Cardinal Health 110, Llc. Dba Leader |
| 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
|
| 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: | 19 Dec, 1992 |
| 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: | Cardinal Health 110, LLC. DBA Leader
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1363309
|
| 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: | 0096295129885
|
| UPC stands for Universal Product Code. |
| UNII: | V1Q0O9OJ9Z
|
| 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]
|
| 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 |
|---|
| 70000-0160-1 | 2 BLISTER PACK in 1 CARTON (70000-0160-1) / 12 TABLET in 1 BLISTER PACK | 19 Dec, 1992 | N/A | No |
| 70000-0160-2 | 1 BOTTLE in 1 CARTON (70000-0160-2) / 100 TABLET in 1 BOTTLE | 19 Dec, 1992 | 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 antihistamine
Product Elements:
Allergy relief 4 hour chlorpheniramine maleate chlorpheniramine maleate chlorpheniramine starch, corn d&c yellow no. 10 aluminum lake anhydrous lactose magnesium stearate microcrystalline cellulose 44;194
Indications and Usage:
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose itchy, watery eyes itching of the nose or throat
Warnings:
Warnings do not use to make a child sleepy. ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. when using this product drowsiness may occur avoid alcoholic beverages excitability may occur, especially in children alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery 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.
Do Not Use:
Warnings do not use to make a child sleepy. ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. when using this product drowsiness may occur avoid alcoholic beverages excitability may occur, especially in children alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery 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.
When Using:
When using this product drowsiness may occur avoid alcoholic beverages excitability may occur, especially in children alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery
Dosage and Administration:
Directions take every 4 to 6 hours, or as directed by a doctor adults and children 12 years and over 1 tablet. do not exceed 6 tablets in 24 hours. children 6 to under 12 years 1/2 tablet (break tablet in half). do not exceed 3 whole tablets in 24 hours. children under 6 years do not use
Package Label Principal Display Panel:
Principal display panel leader ndc 70000-0160-1 4 hour allergy relief chlorpheniramine maleate, 4 mg ? antihistamine relief of: sneezing, runny nose, itchy throat, itchy, watery eyes 24 tablets actual size 100% money back guarantee tamper evident: do not use if package is opened or if blister unit is torn, broken or shows any signs of tampering cin 5294285 rev. 4/20 50844 rev0419a19408 cardinal health distributed by cardinal health dublin, ohio 43017 www.myleader.com 1-800-200-6313 essential to care since 1979 ©2020 cardinal health. all rights reserved. cardinal health, the cardinal health logo, essential to care, leader, and the leader logo are trademarks or registered trademarks of cardinal health. all leader brand products have a 100% money back guarantee return to place of purchase if not satisfied. leader 44-194 leader 44-194
Further Questions:
Questions or comments? 1-800-426-9391