Daytime Nighttime Cold And Cough
Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Doxylamine Succinate
Walgreens
Human Otc Drug
NDC 0363-4670Daytime Nighttime Cold And Cough also known as Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Doxylamine Succinate is a human otc drug labeled by 'Walgreens'. National Drug Code (NDC) number for Daytime Nighttime Cold And Cough is 0363-4670. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Daytime Nighttime Cold And Cough drug includes . The currest status of Daytime Nighttime Cold And Cough drug is Active.
Drug Information:
| Drug NDC: | 0363-4670 |
| 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: | Daytime Nighttime Cold And Cough |
| 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, Phenylephrine Hcl, Doxylamine Succinate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Walgreens |
| 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: | 30 Jul, 2020 |
| 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: | Walgreens
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1043400
1113705
1484901
|
| 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. |
| UPC: | 0311917218649
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 0363-4670-24 | 1 KIT in 1 KIT (0363-4670-24) * 355 mL in 1 BOTTLE * 355 mL in 1 BOTTLE | 30 Jul, 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:
Purposes for day time pain reliever/fever reducer cough suppressant nasal decongestant
Purpose for night time pain reliever/fever reducer cough suppressant antihistamine
Product Elements:
Daytime nighttime cold and cough acetaminophen, dextromethorphan hbr, phenylephrine hcl, doxylamine succinate cold and flu relief acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine anhydrous citric acid fd&c yellow no. 6 glycerin propylene glycol water saccharin sodium sodium benzoate sodium chloride sorbitol sucralose xanthan gum cold and flu nighttime acetaminophen, dextromethorphan hydrobromide, doxylamine succinate acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine acesulfame potassium anhydrous citric acid alcohol d&c yellow no. 10 fd&c green no. 3 fd&c yellow no. 6 propylene glycol water trisodium citrate dihydrate high fructose corn syrup polyethylene glycol, unspecified saccharin sodium
Indications and Usage:
Uses daytime temporarily relieves common cold and flu symptoms minor aches and pains headache sore throat nasal congestion fever cough due to minor throat and bronchial irritation nighttime temporarily relieves common cold/flu symptoms minor aches and pain headache sore throat runny nose and sneezing fever cough due to minor throat and bronchial irritations as may occur with a cold
Warnings:
Warnings daytime nighttime liver warning : this product contain acetaminophen. severe liver damage may occur if: adult takes more than 4 doses (30 ml each) of acetaminophen in 24 hours, which is the maximum daily amount child takes more than 4 doses (15 ml each) in 24 hours taken with other drugs containing acetaminophen adult has 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 daytime nighttime 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
Read more... 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 contain an maoi, ask a doctor or pharmacist before taking this product ask a doctor before use if have daytime liver disease high blood pressure heart disease thyroid disease diabetes a sodium-restricted diet 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) nighttime liver disease glaucoma cough that occurs with too much phlegm (mucus) trouble urinating due to enlarged prostate gland a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis, or emphysema ask a doctor or pharmacist before use if the child is daytime if you are taking the blood thinning drug warfarin nighttime taking sedatives or tranquilizers taking the blood thinning drug warfarin when using this product daytime do not exceed recommended dosage. nighttime excitability may occur, especially in children mark drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives and tranquilizers may increase drowsiness stop use and ask a doctor if daytime nervousness, dizziness or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 5 days (children) or 7 days (adult) 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.persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache. these could be signs of a serious condition. nighttime pain or cough gets worse or lasts more than 7 days redness or swelling is present new symptoms occur fever gets worse or lasts more than 3 days 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 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 adult as well as for children even if you do not notice any signs or symptoms.
Do Not Use:
Warnings daytime nighttime liver warning : this product contain acetaminophen. severe liver damage may occur if: adult takes more than 4 doses (30 ml each) of acetaminophen in 24 hours, which is the maximum daily amount child takes more than 4 doses (15 ml each) in 24 hours taken with other drugs containing acetaminophen adult has 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 daytime nighttime 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 contain an maoi, ask a doctor or pharmacist before taking this product ask a doctor before use if have daytime liver disease high blood pressure heart disease thyroid disease diabetes a sodium-restricted diet 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) nighttime liver disease glaucoma cough that occurs with too much phlegm (mucus) trouble urinating due to enlarged prostate gland a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis, or emphysema ask a doctor or pharmacist before use if the child is daytime if you are taking the blood thinning drug warfarin nighttime taking sedatives or tranquilizers taking the blood thinning drug warfarin when using this product daytime do not exceed recommended dosage. nighttime excitability may occur, especially in children mark drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives and tranquilizers may increase drowsiness stop use and ask a doctor if daytime nervousness, dizziness or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 5 days (children) or 7 days (adult) 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.persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache. these could be signs of a serious condition. nighttime pain or cough gets worse or lasts more than 7 days redness or swelling is present new symptoms occur fever gets worse or lasts more than 3 days 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 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 adult as well as for children even if you do not notice any signs or symptoms.
When Using:
When using this product daytime do not exceed recommended dosage. nighttime excitability may occur, especially in children mark drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives and tranquilizers may increase drowsiness
Dosage and Administration:
Directions daytime do not take more than directed (see overdose warning) do not take more than 4 doses in any 24-hour period measure only with dosing cup provided. do not use any other dosing device. keep dosing cup with product ml= milliliter adult and children 12 years and over 30 ml every 4 hours children 6 to under 12 years 15 ml every 4 hours children 4 to under 6 years ask a doctor children under 4 years do not use nighttime do not take more than directed (see overdose warning) do not take more than 4 doses in any 24-hour period measure only with dosing cup provided. do not use any other dosing device. keep dosing cup with product ml= milliliter adult and children 12 years and over: 30 ml every 6 hours children under 12 years of age: do not use
Stop Use:
Stop use and ask a doctor if daytime nervousness, dizziness or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 5 days (children) or 7 days (adult) 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.persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache. these could be signs of a serious condition. nighttime pain or cough gets worse or lasts more than 7 days redness or swelling is present new symptoms occur fever gets worse or lasts more than 3 days 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 the active ingredients in vick® dayquil® cold & flu & vick® nyquil® cold & flu daytime non-drowsy cold & cough acetaminophen 325 mg / pain reliever / fever reducer dextromethorphan hbr 10 mg / cough suppressant phenylephrine hci 5 mg / nasal decongestant multi-symptom relieves aches, fever,& sore throat, cough & nasal congestion for ages 6 years & over alcohol free antihistamine free fl oz (ml) nighttime cold & flu acetaminophen 650 mg / pain reliever / fever reducer dextromethorphan hbr 30 mg / cough suppressant doxylamine succinate 12.5 mg / antihistamine multi-symptom relieves headache, fever, sore throat, minor aches & pains, sneezing, runny nose & cough for ages 12 years & over nighttime relief alcohol 10% fl oz (ml) when using other daytime or nighttime products, carefully read each label to ensure correct dosing tamper evident: do not use if printed safety seal around dosage cup or under cap is broken or missing keep outer carton for complete warnings and product information these products are not manufactured or distributed by the procter & gamble company. vicks®, dayquil® and nyquil® are registered trademarks of the procter & gamble company. distributed by: walgreen co. 200 wilmot rd., deerfield, il 60015 walgreens.com
Product label walgreens daytime non-drowsy cold & flu, nighttime cold & flu acetaminophen 325 mg, dextromethorphan hbr 10 mg, phenylephrine hcl 5 mg, acetaminophen 650 mg, dextromethorphan hbr 30 mg, doxylamine succinate 12.5 mg
Further Questions:
Questions or comments? call 1-877-753-3935 monday-friday 9am-5pm est