Careone Day Severe Cold Night Cold And Flu
Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl, Doxylamine Succinate
American Sales Company
Human Otc Drug
NDC 41520-997Careone Day Severe Cold Night Cold And Flu also known as Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl, Doxylamine Succinate is a human otc drug labeled by 'American Sales Company'. National Drug Code (NDC) number for Careone Day Severe Cold Night Cold And Flu is 41520-997. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Careone Day Severe Cold Night Cold And Flu drug includes . The currest status of Careone Day Severe Cold Night Cold And Flu drug is Active.
Drug Information:
| Drug NDC: | 41520-997 |
| 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 Day Severe Cold Night Cold And Flu |
| 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, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl, Doxylamine Succinate |
| 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: | Kit |
| 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: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| 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: | 25 Aug, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 07 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: | American Sales Company
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1297288
1656815
1657147
|
| 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: | |
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 41520-997-90 | 1 KIT in 1 KIT (41520-997-90) * 8 BLISTER PACK in 1 CARTON / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 4 BLISTER PACK in 1 CARTON / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 25 Aug, 2017 | 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 â day severe cold pain reliever/fever reducer cough suppressant expectorant nasal decongestant
Purposes â night cold & flu pain reliever/fever reducer cough suppressant antihistamine nasal decongestant
Product Elements:
Careone day severe cold night cold and flu acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, doxylamine succinate careone day severe cold acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan guaifenesin guaifenesin phenylephrine hydrochloride phenylephrine fd&c red no. 40 fd&c yellow no. 6 gelatin glycerin polyethylene glycol povidone propylene glycol water 7g0 careone night cold and flu acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine phenylephrine hydrochloride phenylephrine d&c yellow no. 10 fd&c blue no. 1 gelatin glycerin polyethylene glycol povidone propylene glycol water 345
Indications and Usage:
Uses ⢠temporarily relieves these common cold and flu symptoms: ⢠cough ⢠minor aches and pains ⢠headache ⢠nasal congestion ⢠sore throat ⢠runny nose and sneezing (night only) ⢠helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (day only) ⢠controls cough to help you get to sleep (night only) ⢠temporarily reduces fever
Warnings:
Warnings liver warning: these products contain acetaminophen. severe liver damage may occur if you take ⢠more than 4,000 mg of acetaminophen in 24 hours ⢠with other drugs containing acetaminophen ⢠3 or more alcoholic drinks every day while using these products allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: ⢠skin reddening ⢠blisters ⢠rash if a skin reaction occurs, stop use and seek medical help right away. sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do Not Use:
Warnings liver warning: these products contain acetaminophen. severe liver damage may occur if you take ⢠more than 4,000 mg of acetaminophen in 24 hours ⢠with other drugs containing acetaminophen ⢠3 or more alcoholic drinks every day while using these products allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: ⢠skin reddening ⢠blisters ⢠rash if a skin reaction occurs, stop use and seek medical help right away. sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
When Using:
When using these products ⢠do not use more than directed ⢠excitability may occur, especially in children (night only) ⢠marked drowsiness may occur (night only) ⢠alcohol, sedatives, and tranquilizers may increase drowsiness (night only) ⢠avoid alcoholic drinks (night only) ⢠be careful when driving a motor vehicle or operating machinery (night only)
Dosage and Administration:
Directions ⢠do not take more than directed (see overdose warning) ⢠do not take more than 10 liquid gels in any 24-hour period ⢠adults and children 12 years of age and older: take 2 liquid gels every 4 hours ⢠children under 12 years of age: do not use
Stop Use:
Stop use and ask a doctor if ⢠nervousness, dizziness, or sleeplessness occur ⢠pain, nasal congestion or cough gets worse or lasts more than 7 days ⢠fever gets worse or lasts more than 3 days ⢠redness or swelling is present ⢠new symptoms occur ⢠cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition.
Package Label Principal Display Panel:
Package/label principal display panel combination pack compare to the active ingredients in mucinex® fast-max® day severe cold day severe cold pain reliever/fever reducer â acetaminophen cough suppressant â dextromethorphan hbr expectorant â guaifenesin nasal decongestant â phenylephrine hcl maximum strength relieves aches, fever & sore throat controls cough relieves nasal & chest congestion thins & loosens mucus fast dissolving liquid gels for ages 12+ gluten free actual size our pharmacists recommend 16 liquid gels (liquid filled capsules) compare to the active ingredients in mucinex® fast-max® night cold & flu night cold & flu pain reliever/fever reducer â acetaminophen cough suppressant â dextromethorphan hbr antihistamine â doxylamine succinate nasal decongestant â phenylephrine hcl maximum strength relieves aches, fever & sore throat controls cough relieves nasal congestion relieves runny nose & sneezing fast dissolving liquid gels for ages 12+ gluten free actual size our pharmacists recommend 8 liquid gels (liquid filled capsules) day severe cold night cold & flu carton image 1 day severe cold night cold & flu carton image 2
Further Questions:
Questions or comments? 1-800-719-9260