Cold And Flu Severe Daytime And Nighttime

Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride

Chain Drug Marketing Association Inc.
Human Otc Drug
NDC 63868-238

Cold And Flu Severe Daytime And Nighttime also known as Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride is a human otc drug labeled by 'Chain Drug Marketing Association Inc.'. National Drug Code (NDC) number for Cold And Flu Severe Daytime And Nighttime is 63868-238. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Cold And Flu Severe Daytime And Nighttime drug includes . The currest status of Cold And Flu Severe Daytime And Nighttime drug is Active.

Drug Information:

Drug NDC:	63868-238
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 And Flu Severe Daytime And Nighttime
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, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Chain Drug Marketing Association 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:	01 Sep, 2017
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	23 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:	CHAIN DRUG MARKETING ASSOCIATION INC.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1086991 1110988 1801964
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
63868-238-16	1 KIT in 1 CARTON (63868-238-16) * 8 TABLET, COATED in 1 BLISTER PACK * 8 TABLET, COATED in 1 BLISTER PACK	01 Sep, 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.

Other medicines with the same generic name

Cold And Flu Severe Daytime Nighttime

Acetaminophen & more..

Kit
MEIJER
NDC: 41250-753

Cold And Flu Severe

Acetaminophen & more..

Kit
DISCOUNT DRUG MART
NDC: 53943-186

Tylenol Cold Plus Flu Severe Day/night

Acetaminophen & more..

Kit
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
NDC: 50580-414

Cold Flu Severe Day Night

Acetaminophen & more..

Kit
HEB
NDC: 37808-286

Cold And Flu Severe Daytime And Nighttime

Acetaminophen & more..

Kit
CHAIN DRUG MARKETING ASSOCIATION INC.
NDC: 63868-238

Cold Flu Severe Day Night

Acetaminophen & more..

Kit
Harris Teeter
NDC: 72036-186

Purpose:

Active ingredients (in each caplet) purpose acetaminophen 325 mg pain reliever/fever reducer dextromethorphan hbr 10 mg cough suppressant guaifenesin 200 mg expectorant phenylephrine hcl 5 mg nasal decongestant

Product Elements:

Cold and flu severe daytime and nighttime acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride acesulfame potassium silicon dioxide croscarmellose sodium crospovidone d&c yellow no. 10 aluminum oxide fd&c blue no. 2 magnesium stearate maltodextrin cellulose, microcrystalline polyethylene glycol, unspecified polyvinyl alcohol povidone starch, pregelatinized corn propylene glycol stearic acid talc titanium dioxide acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan guaifenesin guaifenesin phenylephrine hydrochloride phenylephrine aaa;1136 acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride acesulfame potassium silicon dioxide croscarmellose sodium fd&c blue no. 1 aluminum oxide magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified povidone starch, pregelatinized corn propylene glycol stearic acid talc titanium dioxide acetaminophen acetaminophen chlorpheniramine maleate chlorpheniramine dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine aaa;1139

Indications and Usage:

Uses for the temporary relief of the following cold/flu symptoms: minor aches and pain headache sore throat nasal congestion cough helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever

Uses for the temporary relief of the following cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough sinus congestion and pressure sneezing and runny nose helps clear nasal passages relieves cough to help you sleep temporarily reduces fever

Warnings:

r 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. if you have ever had an allergic reaction to this product or any of its ingredients ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin when using this product do not exceed recommended dosage 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. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. overdose warning in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222). quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

r 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. if you have ever had an allergic reaction to this product or any of its ingredients ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes 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) a breathing problem such as emphysema or chronic bronchitis glaucoma ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers when using this product do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery 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. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. overdose warning in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222). 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 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 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. if you have ever had an allergic reaction to this product or any of its ingredients ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin when using this product do not exceed recommended dosage 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. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. overdose warning in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222). quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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 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 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. if you have ever had an allergic reaction to this product or any of its ingredients ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes 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) a breathing problem such as emphysema or chronic bronchitis glaucoma ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers when using this product do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery 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. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. overdose warning in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222). 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

When using this product do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery

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 â do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years ask a doctor

Directions do not use more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours swallow whole â 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 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.

Overdosage:

Overdose warning in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222). quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Package Label Principal Display Panel:

Principal display panel quality choiceÂ® ndc 63868-238-16 cold + flu severe for adults daytime + nighttime pain reliever | fever reducer, cough suppressant, nasal decongestant, expectorant day | acetaminophen, dextromethorphan hbr, phenylephrine hcl, guaifenesin for relief of: head + body aches fever + sore throat cough, nasal congestion mucus + chest congestion pain reliever | fever reducer, antihistamine, cough suppressant, nasal decongestant night | acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl for relief of: head + body aches fever + sore throat cough, nasal congestion runny nose total 24 cool taste caplets 16 day caplets / 8 night caplets image description

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.