Cold Medicine
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl
Selder, S.a. De C.v.
Human Otc Drug
NDC 63654-275Cold Medicine also known as Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl is a human otc drug labeled by 'Selder, S.a. De C.v.'. National Drug Code (NDC) number for Cold Medicine is 63654-275. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Cold Medicine drug includes Acetaminophen - 325 mg/1 Chlorpheniramine Maleate - 2 mg/1 Phenylephrine Hydrochloride - 5 mg/1 . The currest status of Cold Medicine drug is Active.
Drug Information:
| Drug NDC: | 63654-275 |
| 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 Medicine |
| 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: | Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Selder, S.a. De C.v. |
| 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: | ACETAMINOPHEN - 325 mg/1
CHLORPHENIRAMINE MALEATE - 2 mg/1
PHENYLEPHRINE HYDROCHLORIDE - 5 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: | 15 Nov, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Dec, 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: | Selder, S.A. de C.V.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1046781
|
| 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: | 362O9ITL9D
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 |
|---|
| 63654-275-20 | 2 BLISTER PACK in 1 CARTON (63654-275-20) / 10 TABLET in 1 BLISTER PACK | 15 Nov, 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:
Purposes pain reliever/fever reducer antihistamine nasal decongestant
Product Elements:
Cold medicine acetaminophen, chlorpheniramine maleate, phenylephrine hcl acetaminophen acetaminophen chlorpheniramine maleate chlorpheniramine phenylephrine hydrochloride phenylephrine starch, corn crospovidone hypromelloses microcrystalline cellulose polyethylene glycol, unspecified povidone stearic acid az;275
Indications and Usage:
Uses temporarily relieves: â minor aches and pains â headaches â nasal congestion â sinus congestion & pressure â runny nose â sneezing
Warnings:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take: â more than 12 tablets in 24 hours, which is the maximum daily amount â with other drugs containing acetaminophen â 3 or more alcoholic drinks every day while using this product. allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: â skin reddening â blisters â rash if a skin reaction occurs, stop use and seek medical help right away. do not use â if you are allergic to acetaminophen â more than 10 days unless directed by a doctor â 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 â with any other drug containing acetaminophe
Read more...n (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ask a doctor before use if you have â liver disease â heart disease â glaucoma â high blood pressure â thyroid disease â diabetes â trouble urinating due to an enlarged prostate gland â a breathing problem such as emphysema or chronic bronchitis ask a doctor or pharmacist before use if you â are taking the blood thinning drug warfarin â are taking sedatives or tranquilizers when using this product â do not use more than directed â excitability may occur, especially in children â may cause drowsiness n alcohol, sedatives, and tranquilizers may increase drowsiness â avoid alcoholic drinks n be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if â redness or swelling is present â new symptoms occur â you get nervous, dizzy, or sleepless n pain or nasal congestion gets worse or lasts for more than 7 days â fever gets worse or lasts for more than 3 days if pregnant or breast-feeding, if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. keep out of reach of children. in case of overdose, contact a poison control center (1-800-222-1222) immediately. prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do Not Use:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take: â more than 12 tablets in 24 hours, which is the maximum daily amount â with other drugs containing acetaminophen â 3 or more alcoholic drinks every day while using this product. allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: â skin reddening â blisters â rash if a skin reaction occurs, stop use and seek medical help right away. do not use â if you are allergic to acetaminophen â more than 10 days unless directed by a doctor â 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 â with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ask a doctor before use if you have â liver disease â heart disease â glaucoma â high blood pressure â thyroid disease â diabetes â trouble urinating due to an enlarged prostate gland â a breathing problem such as emphysema or chronic bronchitis ask a doctor or pharmacist before use if you â are taking the blood thinning drug warfarin â are taking sedatives or tranquilizers when using this product â do not use more than directed â excitability may occur, especially in children â may cause drowsiness n alcohol, sedatives, and tranquilizers may increase drowsiness â avoid alcoholic drinks n be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if â redness or swelling is present â new symptoms occur â you get nervous, dizzy, or sleepless n pain or nasal congestion gets worse or lasts for more than 7 days â fever gets worse or lasts for more than 3 days if pregnant or breast-feeding, if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. keep out of reach of children. in case of overdose, contact a poison control center (1-800-222-1222) immediately. prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
When Using:
When using this product â do not use more than directed â excitability may occur, especially in children â may cause drowsiness n alcohol, sedatives, and tranquilizers may increase drowsiness â avoid alcoholic drinks n be careful when driving a motor vehicle or operating machinery
Dosage and Administration:
Directions â do not use more than directed â adults and children 12 years of age and older: take 2 tablets every 6 hours. do not take more than 12 tablets in 24 hours. â children under 12 years of age: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
Stop Use:
Stop use and ask a doctor if â redness or swelling is present â new symptoms occur â you get nervous, dizzy, or sleepless n pain or nasal congestion gets worse or lasts for more than 7 days â fever gets worse or lasts for more than 3 days
Package Label Principal Display Panel:
Principal display panel xl-3 cold medicine xl-3 cold medicine
Further Questions:
Questions and comments? 1-888-952-0050 monday through friday 9 am - 5 pm est