Nite Time Cold And Flu
Acetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate, Dextromethorphan Hydrobromide
Puracap Pharmaceutical Llc
Human Otc Drug
NDC 51013-400Nite Time Cold And Flu also known as Acetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate, Dextromethorphan Hydrobromide is a human otc drug labeled by 'Puracap Pharmaceutical Llc'. National Drug Code (NDC) number for Nite Time Cold And Flu is 51013-400. This drug is available in dosage form of Capsule, Liquid Filled. The names of the active, medicinal ingredients in Nite Time Cold And Flu drug includes Acetaminophen - 325 mg/1 Dextromethorphan Hydrobromide - 10 mg/1 Doxylamine Succinate - 6.25 mg/1 Phenylephrine Hydrochloride - 5 mg/1 . The currest status of Nite Time Cold And Flu drug is Active.
Drug Information:
| Drug NDC: | 51013-400 |
| 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: | Nite Time 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, Phenylephrine Hydrochloride, Doxylamine Succinate, Dextromethorphan Hydrobromide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Puracap Pharmaceutical Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Capsule, Liquid Filled |
| 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: | ACETAMINOPHEN - 325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE - 10 mg/1
DOXYLAMINE SUCCINATE - 6.25 mg/1
PHENYLEPHRINE HYDROCHLORIDE - 5 mg/1
|
| 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: | 17 Jul, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 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: | PuraCap Pharmaceutical LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1297288
|
| 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: | 362O9ITL9D
9D2RTI9KYH
V9BI9B5YI2
04JA59TNSJ
|
| 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. |
| Pharmacologic Class: | Adrenergic alpha1-Agonists [MoA]
Antihistamine [EPC]
Histamine Receptor Antagonists [MoA]
Sigma-1 Agonist [EPC]
Sigma-1 Receptor Agonists [MoA]
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]
Uncompetitive NMDA Receptor Antagonists [MoA]
alpha-1 Adrenergic Agonist [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 51013-400-01 | 1 BLISTER PACK in 1 CARTON (51013-400-01) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 17 Jul, 2017 | N/A | No |
| 51013-400-06 | 1 BLISTER PACK in 1 CARTON (51013-400-06) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 17 Jul, 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. |
Purpose:
Purposes pain reliever/fever reducer cough suppressant antihistamine nasal decongestant
Product Elements:
Nite time cold and flu acetaminophen, phenylephrine hydrochloride, doxylamine succinate, dextromethorphan hydrobromide acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine phenylephrine hydrochloride phenylephrine d&c yellow no. 10 fd&c blue no. 1 gelatin glycerin polyethylene glycol, unspecified povidone propylene glycol water sorbitol sorbitan clear oblong pc22
Indications and Usage:
Uses temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache nasal and sinus congestion cough sore throat runny nose sneezing temporarily reduces fever
Warnings:
Warnings liver warning this product contains acetaminophen. severe liver damage may occur if you take more than 10 softgels 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 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. 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. do not use to sedate children. 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 condition
Read more...s, 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. in children under 12 years of age ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough with excessive phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema 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 may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children stop use and ask a doctor if pain, cough, or nasal congestion 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. nervousness, dizziness, or sleeplessness occurs if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away. 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. severe liver damage may occur if you take more than 10 softgels 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 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. 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. do not use to sedate children. 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. in children under 12 years of age ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough with excessive phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema 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 may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children stop use and ask a doctor if pain, cough, or nasal congestion 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. nervousness, dizziness, or sleeplessness occurs if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away. 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 may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children
Dosage and Administration:
Directions do not take more than the recommended dose adults and children 12 years and over: take 2 softgels with water every 4 hours. do not exceed 10 softgels in 24 hours or as directed by a doctor. children under 12 years: do not use
Stop Use:
Stop use and ask a doctor if pain, cough, or nasal congestion 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. nervousness, dizziness, or sleeplessness occurs
Package Label Principal Display Panel:
Principal display panel - 8ct nite time cold & flu 8 softgels ndc 51013-400-06 * compare to the active ingredients in alka-seltzer plus ® night cold and flu formula carton front 8ct carton back 8ct
Principal display panel - 10ct nite time cold & flu 10 softgels ndc 51013-400-01 * compare to the active ingredients in alka-seltzer plus ® night cold and flu formula icarton front 10ct carton back 10ct
Further Questions:
Questions or comments? call toll free: 1-855-215-8180