Comtrex Cough And Cold Day/night
Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, And Chlorpheniramine Maleate
Dr. Reddy's Laboratories Inc.
Human Otc Drug
NDC 55741-524Comtrex Cough And Cold Day/night also known as Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, And Chlorpheniramine Maleate is a human otc drug labeled by 'Dr. Reddy's Laboratories Inc.'. National Drug Code (NDC) number for Comtrex Cough And Cold Day/night is 55741-524. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Comtrex Cough And Cold Day/night drug includes . The currest status of Comtrex Cough And Cold Day/night drug is Active.
Drug Information:
| Drug NDC: | 55741-524 |
| 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: | Comtrex Cough And Cold Day/night |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Comtrex Cough And Cold |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Day/Night |
| 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: | Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, And Chlorpheniramine Maleate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Dr. Reddy's Laboratories Inc. |
| 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: | 24 May, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 Jun, 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: | Dr. Reddy's Laboratories Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1086991
1094538
1112908
|
| 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 |
|---|
| 55741-524-24 | 1 KIT in 1 CARTON (55741-524-24) * 12 TABLET, COATED in 1 BLISTER PACK * 12 TABLET, COATED in 1 BLISTER PACK | 24 May, 2016 | 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:
Active ingredients (in each caplet) (cold multi-symptom day) purpose acetaminophen 325 mg pain reliever/fever reducer dextromethorphan hbr 10 mg cough suppressant phenylephrine hcl 5 mg nasal decongestant active ingredients (in each caplet) (cold multi-symptom night) purpose acetaminophen 325 mg pain reliever/fever reducer chlorpheniramine maleate 2 mg antihistamine dextromethorphan hbr 10 mg cough suppressant phenylephrine hcl 5 mg nasal decongestant
Product Elements:
Comtrex cough and cold day/night acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and chlorpheniramine maleate comtrex cold multi-symptom day caplet acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine starch, corn croscarmellose sodium crospovidone d&c yellow no. 10 fd&c yellow no. 6 aluminum oxide hypromelloses magnesium stearate cellulose, microcrystalline polydextrose polyethylene glycol, unspecified povidone, unspecified silicon dioxide stearic acid sucralose titanium dioxide triacetin oblong cx comtrex cold multi-symptom night caplet acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and chlorpheniramine maleate acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine chlorpheniramine maleate chlorpheniramine starch, corn crospovidone fd&c blue no. 1 fd&c blue no. 2 aluminum oxide magnesium stearate cellulose, microcrystalline polyethylene glycol, unspecified polyvinyl alcohol povidone, unspecified silicon dioxide sodium starch glycolate type a corn stearic acid sucralose talc titanium dioxide oblong cx
Indications and Usage:
Uses temporarily relieves these common cold/flu symptoms: headache minor aches and pains nasal congestion sinus congestion and pressure sore throat cough sneezing and runny nose (cold night only) helps clear nasal passages temporarily reduces fever promotes nasal and sinus drainage (cold day only) relieves cough to help you sleep (cold night only)
Warnings:
Warnings liver warning this product contains acetaminophen. the maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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 this product 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 with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine 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 do not know if your prescription drug contains an maoi, ask a doctor or pharmacis
Read more...t before taking this product. ask a doctor before use if you have diabetes high blood pressure heart disease thyroid disease liver disease trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) glaucoma (cold night only) a breathing problem such as emphysema or chronic bronchitis (cold night only) ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (cold night only) when using this product do not exceed recommended dosage avoid alcoholic drinks (cold night only) marked drowsiness may occur (cold night only) alcohol, sedatives, and tranquilizers may increase drowsiness (cold night only) excitability may occur, especially in children (cold night only) be careful when driving a motor vehicle or operating machinery (cold night only) stop use and ask a doctor if fever gets worse or lasts more than 3 days new symptoms occur nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days a persistent cough may be a sign of a serious condition. if cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor. redness or swelling is present these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. overdose warning taking more than the recommended dose (overdose) may cause liver damage. in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away. quick 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. the maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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 this product 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 with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine 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 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 diabetes high blood pressure heart disease thyroid disease liver disease trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) glaucoma (cold night only) a breathing problem such as emphysema or chronic bronchitis (cold night only) ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (cold night only) when using this product do not exceed recommended dosage avoid alcoholic drinks (cold night only) marked drowsiness may occur (cold night only) alcohol, sedatives, and tranquilizers may increase drowsiness (cold night only) excitability may occur, especially in children (cold night only) be careful when driving a motor vehicle or operating machinery (cold night only) stop use and ask a doctor if fever gets worse or lasts more than 3 days new symptoms occur nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days a persistent cough may be a sign of a serious condition. if cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor. redness or swelling is present these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. overdose warning taking more than the recommended dose (overdose) may cause liver damage. in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away. quick 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 do not exceed recommended dosage avoid alcoholic drinks (cold night only) marked drowsiness may occur (cold night only) alcohol, sedatives, and tranquilizers may increase drowsiness (cold night only) excitability may occur, especially in children (cold night only) be careful when driving a motor vehicle or operating machinery (cold night only)
Dosage and Administration:
Directions do not take more than directed (see overdose warning ) adults and children 12 years and over: take 2 caplets every 4 hours swallow whole - do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor
Stop Use:
Stop use and ask a doctor if fever gets worse or lasts more than 3 days new symptoms occur nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days a persistent cough may be a sign of a serious condition. if cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor. redness or swelling is present these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel - kit carton ndc 55741-524-24 comtrex ® cold & cough day acetaminophen â pain reliever â fever reducer dextromethorphan hbr â cough suppressant phenylephrine hcl â nasal decongestant 12 coated caplets night acetaminophen â pain reliever â fever reducer chlorpheniramine maleate â antihistamine dextromethorphan hbr â cough suppressant phenylephrine hcl â nasal decongestant 12 coated caplets principal display panel - kit carton
Further Questions:
Questions or comments? 1-800-790-6417