Cold And Flu Daytime, Nighttime, Multi-symptom
Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl
Spirit Pharmaceuticals Llc
Human Otc Drug
NDC 68210-4111Cold And Flu Daytime, Nighttime, Multi-symptom also known as Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl is a human otc drug labeled by 'Spirit Pharmaceuticals Llc'. National Drug Code (NDC) number for Cold And Flu Daytime, Nighttime, Multi-symptom is 68210-4111. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Cold And Flu Daytime, Nighttime, Multi-symptom drug includes . The currest status of Cold And Flu Daytime, Nighttime, Multi-symptom drug is Active.
Drug Information:
| Drug NDC: | 68210-4111 |
| 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 Daytime, Nighttime, Multi-symptom |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Cold And Flu |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Daytime, Nighttime, Multi-Symptom |
| 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 Hbr, Doxylamine Succinate, Phenylephrine Hcl |
| 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: | 16 Sep, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 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
1094549
1311150
|
| 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 |
|---|
| 68210-4111-1 | 1 KIT in 1 PACKAGE, COMBINATION (68210-4111-1) * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 16 Sep, 2020 | 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:
Purpose pain reliever/fever reducer cough suppressant nasal decongestant
Purpose pain reliever/fever reducer cough suppressant antihistamine
Product Elements:
Cold and flu daytime, nighttime, multi-symptom acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl cold and flu daytime, multi-symptom acetaminophen, dextromethorphan hbr, phenylephrine hcl polyethylene glycol 400 titanium dioxide povidone k30 propylene glycol sorbitol gelatin water acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine fd&c red no. 40 fd&c yellow no. 6 glycerin orange to red 512 softgels cold and flu nighttime, multi-symptom acetaminophen, dextromethorphan hbr, doxylamine succinate d&c yellow no. 10 fd&c blue no. 1 titanium dioxide gelatin glycerin povidone k30 propylene glycol polyethylene glycol 400 sorbitol water acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine 215
Indications and Usage:
Uses temporarily relieves common cold and flu symptoms: fever headache sore throat minor aches and pains cough due to minor throat and bronchial irritation 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 4,000 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 d
Read more...rug. 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 difficulty in urination due to enlargement of the prostate gland heart disease (daytime only) diabetes (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 exceed recommended dosage excitability may occur, especially in children (nighttime only) avoid alcoholic beverages (nighttime only) marked drowsiness may occur (nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (nighttime only) use caution when driving a motor vehicle or operating machinery (nighttime only) stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur (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. in case of accidental overdose, get medical help or contact a poison control center (1-800-222-1222) right away. prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. if taking nighttime and daytime products, carefully read each section to ensure correct dosing.
Do Not Use:
Warnings liver warning: this product contains 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 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 difficulty in urination due to enlargement of the prostate gland heart disease (daytime only) diabetes (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 exceed recommended dosage excitability may occur, especially in children (nighttime only) avoid alcoholic beverages (nighttime only) marked drowsiness may occur (nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (nighttime only) use caution when driving a motor vehicle or operating machinery (nighttime only) stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur (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. in case of accidental overdose, get medical help or contact a poison control center (1-800-222-1222) right away. prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. if taking nighttime and daytime products, carefully read each section to ensure correct dosing.
When Using:
When using this product do not exceed recommended dosage excitability may occur, especially in children (nighttime only) avoid alcoholic beverages (nighttime only) marked drowsiness may occur (nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (nighttime only) use caution when driving a motor vehicle or operating machinery (nighttime only)
Dosage and Administration:
Directions (daytime only) do not take more than directed do not take more than 8 capsules per 24 hours adults and children 12 years and over: take 2 capsules with water every 4 hours children under 12 years: ask a doctor
Directions (nighttime only) do not take more than directed do not take more than 8 capsules per 24 hours adults and children 12 years and over: take 2 capsules with water every 6 hours children under 12 years: ask a doctor
Stop Use:
Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur (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.
Package Label Principal Display Panel:
Principal display panel compare to vicks® dayquil® & nyquil® cold & flu liquicaps® active ingredients daytime non drowsy cold & flu acetaminophen / pain reliever / fever reducer dextromethorphan hbr / cough suppressant phenylephrine hcl / nasal decongestant multi-symptom actual size 32 liquid caps nighttime cold & flu acetaminophen / pain reliever / fever reducer dextromethorphan hbr / cough suppressant doxylamine succinate / antihistamine multi-symptom actual size 16 liquid caps 48 total liquid caps tamper evident: do not use if package is opened or if blister unit is torn, broken or shows any signs of tampering walgreens pharmacist recommended walgreens pharmacist survey this product is not manufactured or distributed by procter & gamble, owner of the registered trademark vicks® dayquil® & nyquil® cold & flu liquicaps®. image description
Further Questions:
Questions or comments? 1-888-333-9792