Cold And Flu Non Drowsy Daytime And Nighttime

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride


Spirit Pharmaceuticals Llc
Human Otc Drug
NDC 68210-4214
Cold And Flu Non Drowsy Daytime And Nighttime also known as Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride is a human otc drug labeled by 'Spirit Pharmaceuticals Llc'. National Drug Code (NDC) number for Cold And Flu Non Drowsy Daytime And Nighttime is 68210-4214. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Cold And Flu Non Drowsy Daytime And Nighttime drug includes . The currest status of Cold And Flu Non Drowsy Daytime And Nighttime drug is Active.

Drug Information:

Drug NDC: 68210-4214
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 Non Drowsy 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, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Spirit Pharmaceuticals Llc
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: 19 Oct, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 16 Jan, 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:Spirit Pharmaceuticals LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1086997
1094538
1426334
2619026
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
68210-4214-11 KIT in 1 CARTON (68210-4214-1) * 1 BLISTER PACK in 1 CARTON / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK19 Oct, 2022N/ANo
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 cold & flu non drowsy day relief pain reliever/fever reducer cough suppressant nasal decongestant cold & flu night relief pain reliever/fever reducer cough suppressant antihistamine

Product Elements:

Cold and flu non drowsy daytime and nighttime acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride cold and flu non drowsy day relief acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride fd&c red no. 40 fd&c yellow no. 6 gelatin glycerin lecithin, soybean medium-chain triglycerides polyethylene glycol 400 povidone propylene glycol sorbitol titanium dioxide acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine 512;a09;ap01 cold and flu night relief acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride d&c yellow no. 10 fd&c blue no. 1 gelatin glycerin lecithin, soybean medium-chain triglycerides polyethylene glycol 400 povidone propylene glycol sorbitol sorbitan titanium dioxide acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine 116;a07;ap02

Indications and Usage:

Uses temporarily relieves common cold/flu symptoms: fever headache minor aches and pain cough due to minor throat and bronchial iffitation sore throat nasal congestion (daytime only) runny nose and sneezing (nighttime only)

Warnings:

Warnings liver warning this product contains acetaminophen. severe liver damage may occur if you take: ? more than 4 doses in 24 hours, which is the maximum daily amount for this product ? 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 d
isease), 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? to make a child sleepy (nighttime only) ask a doctor before use if you have ? cough that occurs with too much phlegm (mucus) ? liver disease ? trouble urinating due to enlarged prostate gland ? diabetes (daytime only) ? heart disease (daytime only) ? thyroid disease (daytime only) ? high blood pressure (daytime only) ? persistent or chronic cough such as occurs with smoking, asthma, or emphysema (daytime only) ? a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (nighttime only) ? glaucoma (nighttime only) ask a doctor or pharmacist before use if you are ? taking the blood thinning drug warfarin ? taking sedatives or tranquilizers (nighttime only) when using this product ? do not take more than directed ? marked drowsiness may occur (nighttime only) ? avoid alcoholic drinks (nighttime only) ? excitability may occur, especially in children (nighttime only) ? be careful when driving a motor vehicle or operating machinery (nighttime only) ? alcohol, sedatives, and tranquilizers may increase drowsiness (nighttime only) stop use and ask a doctor if ? you get nervous, dizzy or sleepless (daytime only) ? pain, nasal congestion, or cough gets worse or lasts more than 7 days (daytime only) ? pain or cough gets worse or lasts more than 7 days (nighttime only) ? 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 taking more than directed can cause serious health problems. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical for adults & 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: ? more than 4 doses in 24 hours, which is the maximum daily amount for this product ? 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? to make a child sleepy (nighttime only) ask a doctor before use if you have ? cough that occurs with too much phlegm (mucus) ? liver disease ? trouble urinating due to enlarged prostate gland ? diabetes (daytime only) ? heart disease (daytime only) ? thyroid disease (daytime only) ? high blood pressure (daytime only) ? persistent or chronic cough such as occurs with smoking, asthma, or emphysema (daytime only) ? a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (nighttime only) ? glaucoma (nighttime only) ask a doctor or pharmacist before use if you are ? taking the blood thinning drug warfarin ? taking sedatives or tranquilizers (nighttime only) when using this product ? do not take more than directed ? marked drowsiness may occur (nighttime only) ? avoid alcoholic drinks (nighttime only) ? excitability may occur, especially in children (nighttime only) ? be careful when driving a motor vehicle or operating machinery (nighttime only) ? alcohol, sedatives, and tranquilizers may increase drowsiness (nighttime only) stop use and ask a doctor if ? you get nervous, dizzy or sleepless (daytime only) ? pain, nasal congestion, or cough gets worse or lasts more than 7 days (daytime only) ? pain or cough gets worse or lasts more than 7 days (nighttime only) ? 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 taking more than directed can cause serious health problems. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

When Using:

When using this product ? do not take more than directed ? marked drowsiness may occur (nighttime only) ? avoid alcoholic drinks (nighttime only) ? excitability may occur, especially in children (nighttime only) ? be careful when driving a motor vehicle or operating machinery (nighttime only) ? alcohol, sedatives, and tranquilizers may increase drowsiness (nighttime only)

Dosage and Administration:

Directions ? when using other daytime and nighttime products, carefully read each label to ensure correct dosing directions (daytime only) ? take only as directed - see overdose warning ? do not exceed 4 doses per 24 hours adults & children 12 years & over take 2 softgels with water every 4 hours children 4 to under 12 years ask a doctor children under 4 years of age do not use ? when using other daytime and nighttime products, carefully read each label to ensure correct dosing directions (nighttime only) ? take only as directed - see overdose warning ? do not exceed 4 doses per 24 hours adults & children 12 years & over take 2 softgels with water every 6 hours children 4 to under 12 years ask a doctor children under 4 years of age do not use

Stop Use:

Stop use and ask a doctor if ? you get nervous, dizzy or sleepless (daytime only) ? pain, nasal congestion, or cough gets worse or lasts more than 7 days (daytime only) ? pain or cough gets worse or lasts more than 7 days (nighttime only) ? 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 taking more than directed can cause serious health problems. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Package Label Principal Display Panel:

Principal display panel dt nt cold flu vh

Further Questions:

Questions or comments? 1-888-333-9792


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.