Nighttime Cold And Flu
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Puracap Pharmaceutical Llc
Human Otc Drug
NDC 51013-131Nighttime Cold And Flu also known as Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate is a human otc drug labeled by 'Puracap Pharmaceutical Llc'. National Drug Code (NDC) number for Nighttime Cold And Flu is 51013-131. This drug is available in dosage form of Capsule, Liquid Filled. The names of the active, medicinal ingredients in Nighttime Cold And Flu drug includes Acetaminophen - 325 mg/1 Dextromethorphan Hydrobromide - 15 mg/1 Doxylamine Succinate - 6.25 mg/1 . The currest status of Nighttime Cold And Flu drug is Active.
Drug Information:
| Drug NDC: | 51013-131 |
| 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: | 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 Hydrobromide, Doxylamine Succinate |
| 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 - 15 mg/1
DOXYLAMINE SUCCINATE - 6.25 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: | 30 Jun, 2016 |
| 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: | PuraCap Pharmaceutical LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1094549
|
| 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
|
| 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: | 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]
|
| 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 |
|---|
| 51013-131-08 | 2 BLISTER PACK in 1 CARTON (51013-131-08) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 30 Jun, 2016 | 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 antihistamine
Product Elements:
Nighttime cold and flu acetaminophen, dextromethorphan hydrobromide, doxylamine succinate acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine d&c yellow no. 10 fd&c blue no. 1 gelatin glycerin polyethylene glycol, unspecified povidone propylene glycol water sorbitol clear oblong pc10
Indications and Usage:
Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose & sneezing
Warnings:
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 daily while using this product sore throat warning if sore throat is severe, lasts more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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 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 sto
Read more...pping 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 ask a doctor before use if you have liver disease glaucoma a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus) trouble urinating due to enlarged prostate gland ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin when using this product do not use more than directed excitability may occur, especially in children marked 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 pain or cough 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. 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. 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 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product sore throat warning if sore throat is severe, lasts more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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 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. to make a child sleep ask a doctor before use if you have liver disease glaucoma a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus) trouble urinating due to enlarged prostate gland ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin when using this product do not use more than directed excitability may occur, especially in children marked 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 pain or cough 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. 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. 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 use more than directed excitability may occur, especially in children marked 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 take only as directed - see overdose warning do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 2 softgels with water every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use when using other nighttime or daytime products, carefully read each label to ensure correct dosing
Stop Use:
Stop use and ask a doctor if pain or cough 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.
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 market basket nighttime cold & flu liquid caps 20 softgels ndc 51013-131-08 *compare to the active ingredients in vicks® nyquil® cold & flu carton label
Further Questions:
Questions or comments? call toll free: 1-855-215-8180