Daytime Nighttime Cold And Flu
Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl
Strive Pharmaceuticals Inc.
Human Otc Drug
NDC 70692-602Daytime Nighttime Cold And Flu also known as Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl is a human otc drug labeled by 'Strive Pharmaceuticals Inc.'. National Drug Code (NDC) number for Daytime Nighttime Cold And Flu is 70692-602. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Daytime Nighttime Cold And Flu drug includes . The currest status of Daytime Nighttime Cold And Flu drug is Active.
Drug Information:
| Drug NDC: | 70692-602 |
| 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 Flu |
| 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, Doxylamine Succinate, Phenylephrine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Strive Pharmaceuticals 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: | ORAL
|
| 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: | 06 Nov, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 May, 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: | Strive Pharmaceuticals Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1086997
1094549
1730191
|
| 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: | 0370692602128
|
| 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 |
|---|
| 70692-602-12 | 1 KIT in 1 PACKAGE, COMBINATION (70692-602-12) * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 4 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 06 Nov, 2018 | 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:
Daytime pain reliever/fever reducer, cough suppresant and nasal decongestant nighttime pain reliever/fever reducer, cough suppressant and antihistamine
Product Elements:
Daytime nighttime cold and flu acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl daytime nighttime cold and flu acetaminophen, dextromethorphan hbr , phenylephrine hcl sorbitol titanium dioxide polyethylene glycol 400 povidone fd&c yellow no. 6 food yellow 3 free acid gelatin dextromethorphan hydrobromide dextromethorphan acetaminophen acetaminophen fd&c red no. 40 phenylephrine hydrochloride phenylephrine water glycerin propylene glycol 604 daytime nighttime cold and flu acetaminophen, dextromethorphan hbr, doxylamine succinate titanium dioxide sorbitol polyethylene glycol 400 d&c yellow no. 10 doxylamine succinate doxylamine fd&c blue no. 1 dextromethorphan hydrobromide dextromethorphan gelatin acetaminophen acetaminophen water glycerin povidone propylene glycol 603
Indications and Usage:
* temporarily relieves common cold/flu symptoms: nasal congestion (daytime only) cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing (nighttime only)
Warnings:
Liver warning : this product contains acetaminophen. severe liver damage may occur if you take: *more than 4 doses in 24 hrs, 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 f
Read more...or 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. *to make a child sleep (nighttime only). ask a doctor before use if you have * liver disease * heart disease (daytime only) * high blood pressure (daytime only) * thyroid disease (daytime only) * trouble urinating due to an enlarged prostate gland * glaucoma (nighttime only) * persistent or chronic cough such as occurs with smoking, asthma or emphysema and (nighttime only) chronic bronchitis * cough that occurs with too much phlegm (mucus) ask a doctor or a pharmacist before use if you are * taking the blood thinning drug warfarin * taking sedatives or tranquilizers (nighttime only) when using this product do not use more than directed. in addition when using nighttime: * excitability may occur, especially in children * marked drowsiness may occur * alcohol, sedatives, and tranquilizers may increase drowsiness * be careful when driving a motor vehicle or operating machinery * avoid alcoholic drinks stop use and ask a doctor if * you get nervous, dizzy, or sleepless (daytime only) * pain, cough and nasal congestion (daytime only) may get worse or lasts more than 7 days * new symptoms occur * fever gets worse or lasts more than 3 days * redness or swelling is present * 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 care 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.
Dosage and Administration:
Directions * take only as directed - see overdose warning * do not exceed 4 doses per 24 hrs * take softgels with water read each label carefully before taking daytime and nighttime product daytime nighttime adulta & children age 12 years & over 2 softgels every 4 hours 2 softgels every 6 hours children 4 to under 12 years ask a doctor ask a doctor children under 4 years do not use do not use
Package Label Principal Display Panel:
Daytime nighttime cold & flu