Ed A-hist
Chlorpheniramine/phenylephrine
Edwards Pharmaceuticals, Inc.
Human Otc Drug
NDC 0485-0155Ed A-hist also known as Chlorpheniramine/phenylephrine is a human otc drug labeled by 'Edwards Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Ed A-hist is 0485-0155. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Ed A-hist drug includes Chlorpheniramine Maleate - 4 mg/5mL Phenylephrine Hydrochloride - 10 mg/5mL . The currest status of Ed A-hist drug is Active.
Drug Information:
| Drug NDC: | 0485-0155 |
| 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: | Ed A-hist |
| 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/phenylephrine |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Edwards Pharmaceuticals, Inc. |
| 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: | CHLORPHENIRAMINE MALEATE - 4 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE - 10 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: | 11 Jan, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 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: | Edwards Pharmaceuticals, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1086463
|
| 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: | 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 |
|---|
| 0485-0155-16 | 473 mL in 1 BOTTLE, PLASTIC (0485-0155-16) | 11 Jan, 2011 | 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.........................nasal decongestant
Product Elements:
Ed a-hist chlorpheniramine/phenylephrine glycerin water sodium citrate saccharin sodium sorbitol propylene glycol alcohol chlorpheniramine maleate chlorpheniramine phenylephrine hydrochloride phenylephrine
Indications and Usage:
Uses temporarily relieves runny nose and nasal congestion due to the common cold, hay fever or other upper respiratory allergies allergic rhinitis), relieves sneezing, itching of the nose or throat, itchy watery eyes, and reduces swelling of the nasal passages.
Warnings:
Warnings: do not exceed recommended dosage. do not use this product if you are now taking prescription monaimine 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 know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. do not take this product, unless directed by a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma, heart disease, diabetes, high blood pressure or thyroid disease 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 the product may cause drowsiness 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
Read more...and ask a doctor if nervousness, dizziness, or sleeplessness occurs symptoms do not improve within 7 days or are accompanied by a 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 right away.
Do Not Use:
Warnings: do not exceed recommended dosage. do not use this product if you are now taking prescription monaimine 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 know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. do not take this product, unless directed by a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma, heart disease, diabetes, high blood pressure or thyroid disease 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 the product may cause drowsiness 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 occurs symptoms do not improve within 7 days or are accompanied by a 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 right away.
When Using:
When using the product may cause drowsiness 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 exceed recommended dosage. adults and children 12 years of age and over: 1 teaspoonful (5 ml) every 4 hours, not to exceed 6 teaspoonfuls in a 24 hour period children 6 to under 12 years of age: 1/2 teaspoonful (5 ml) every 4 hours, not to exceed 6 teaspoonfuls in a 24 hour period children under 6 years of age: consult a doctor a special measuring device should be used to give an accurate dose of this product to children under 12 years of age. giving a higher dose than recommended by a doctor could result in serious side effects for your child.
Stop Use:
Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs symptoms do not improve within 7 days or are accompanied by a fever.
Package Label Principal Display Panel:
Product packaging the packaging below represents the labeling currently used: principal display panel and side panel for 473 ml label: ndc 0485-0155-16 ed a-hist liquid antihistamine / decongestant each 5 ml (one teaspoonful) for oral administration contains: chlorpheniramine maleate..............................4 mg phenyleprhing hydrochloride.........................10 mg alcohol usp.....................................................5% gluten free / sugar free do not use if foil seal under cap is broken or missing manufactured for: edwards pharmaceuticals, inc. ripley, ms 38663 net contents: 1 pint (473 ml) tamper evident by foil seal under cap. do not use if foil seal is broken or missing. dispense in a tight, light-resistant container with a child-resistant closure. this bottle is not to be dispensed to consumer. manufactured for: edwards pharmaceuticals, inc., ripley, ms 38663 iss. 12/10 ed a-hist liquid packaging ed a-hist liquid packaging
Further Questions:
Questions or comments? call 1-800-543-9560 iss. 12/10