Mygrin Nighttime
Acetaminophen, Aspirin (nsaid), And Diphenhydramine Citrate
Sunascen Therapeutics Llc
Human Otc Drug
NDC 49467-230Mygrin Nighttime also known as Acetaminophen, Aspirin (nsaid), And Diphenhydramine Citrate is a human otc drug labeled by 'Sunascen Therapeutics Llc'. National Drug Code (NDC) number for Mygrin Nighttime is 49467-230. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Mygrin Nighttime drug includes Acetaminophen - 250 mg/1 Aspirin - 250 mg/1 Diphenhydramine Citrate - 38 mg/1 . The currest status of Mygrin Nighttime drug is Active.
Drug Information:
| Drug NDC: | 49467-230 |
| 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: | Mygrin Nighttime |
| 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, Aspirin (nsaid), And Diphenhydramine Citrate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Sunascen Therapeutics Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Film Coated |
| 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 - 250 mg/1
ASPIRIN - 250 mg/1
DIPHENHYDRAMINE CITRATE - 38 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 NOT 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: | 05 Feb, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 12 Jun, 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: | part343 |
| 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, 2024 |
| 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: | Sunascen Therapeutics LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1593110
|
| 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: | 0349467230101
|
| UPC stands for Universal Product Code. |
| NUI: | N0000000160
N0000008836
M0001335
N0000175722
N0000175578
N0000008832
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 362O9ITL9D
R16CO5Y76E
4OD433S209
|
| 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 MOA: | Cyclooxygenase Inhibitors [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Nonsteroidal Anti-inflammatory Drug [EPC]
Platelet Aggregation Inhibitor [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class PE: | Decreased Prostaglandin Production [PE]
Decreased Platelet Aggregation [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class CS: | Anti-Inflammatory Agents, Non-Steroidal [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Anti-Inflammatory Agents
Non-Steroidal [CS]
Cyclooxygenase Inhibitors [MoA]
Decreased Platelet Aggregation [PE]
Decreased Prostaglandin Production [PE]
Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [EPC]
Nonsteroidal Anti-inflammatory Drug [EPC]
Platelet Aggregation Inhibitor [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 |
|---|
| 49467-230-10 | 1 BOTTLE in 1 CARTON (49467-230-10) / 100 TABLET, FILM COATED in 1 BOTTLE | 05 Feb, 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:
Purpose pain reliever pain reliever nighttime sleep-aid
Product Elements:
Mygrin nighttime acetaminophen, aspirin (nsaid), and diphenhydramine citrate starch, corn crospovidone, unspecified fd&c blue no. 1 hypromellose, unspecified maltodextrin medium-chain triglycerides microcrystalline cellulose polydextrose povidone, unspecified sodium lauryl sulfate sodium starch glycolate type a potato sodium sulfate stearic acid talc titanium dioxide ferric oxide yellow zinc stearate acetaminophen acetaminophen aspirin aspirin diphenhydramine citrate diphenhydramine st230
Indications and Usage:
Indications and usage for the temporary relief of occasional headaches, and minor aches and pains, with accompanying sleeplessness
Warnings:
Warnings reye's syndrome children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. when using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of reye's syndrome, a rare but serious illness. allergy alert (aspirin) aspirin may cause a severe allergic reaction, which may include the following, hives facial swelling shock asthma (wheezing) allergy alert (acetaminophen) acetaminophen may cause severe skin reactions. symptoms may include the following, blisters rash skin reddening if a skin reaction does occur, stop use and seek medical help right away. liver warning this product contains acetaminophen. severe liver damage may occur if you take the following, more than 4,000 mg of acetaminophen in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen three or more alcoholic drinks every day while using this product sto
Read more...mach bleeding warning this product contains an nsaid, which may cause severe stomach bleeding. the chance of severe stomach bleeding is higher if you are age 60 or older have 3 or more alcoholic drinks every day while using this product take more than directed, or for a longer time than directed take other drugs containing prescription or nonprescription nsaids [aspirin, ibuprofen, naproxen or others] have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug do not use do not use this product in the following scenarios, if you ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or non prescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with other products containing diphenhydramine, including any used externally in children under 12 years of age ask a doctor ask a doctor before using this product if, the stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have difficulty in urination due to enlargement of the prostate gland you have liver disease you have high blood pressure, heart disease, liver cirrhosis or kidney disease you have glaucoma you are taking a diuretic you have asthma you have a breathing problem such as emphysema or chronic bronchitis ask a doctor or a pharmacist ask a doctor or pharmacist before using this product if you are taking the following, a prescription drug for: + arthritis + diabetes + gout sedatives or tranquilizers any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer any other drug, or are under a doctor's care for any serious condition when using this product, do not drive a motor vehicle or operate machinery drowsiness may occur avoid alcoholic beverages stop use and ask a doctor stop use of this product and ask a doctor in the event of the following, if an allergic reaction occurs. seek medical help right away. you experience any of signs of stomach bleeding, such as + feeling faint + vomit blood + have bloody or black stools + have stomach pain that does not get better new symptoms occur redness or swelling is present ringing in the ears or loss of hearing occurs your pain gets worse or lasts for more than 10 days sleeplessness persists continuously for more than 2 weeks. insomnia may be a symptom of a serious underlying medical illness. these could be signs of a serious condition pregnancy and nursing mothers if pregnant or breast-feeding ask a health professional before use. it is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. keep out of reach of children in case of an overdose, seek medical help right away or contact a poison control center (1-800-222-1222) immediately. prompt 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 reye's syndrome children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. when using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of reye's syndrome, a rare but serious illness. allergy alert (aspirin) aspirin may cause a severe allergic reaction, which may include the following, hives facial swelling shock asthma (wheezing) allergy alert (acetaminophen) acetaminophen may cause severe skin reactions. symptoms may include the following, blisters rash skin reddening if a skin reaction does occur, stop use and seek medical help right away. liver warning this product contains acetaminophen. severe liver damage may occur if you take the following, more than 4,000 mg of acetaminophen in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen three or more alcoholic drinks every day while using this product stomach bleeding warning this product contains an nsaid, which may cause severe stomach bleeding. the chance of severe stomach bleeding is higher if you are age 60 or older have 3 or more alcoholic drinks every day while using this product take more than directed, or for a longer time than directed take other drugs containing prescription or nonprescription nsaids [aspirin, ibuprofen, naproxen or others] have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug do not use do not use this product in the following scenarios, if you ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or non prescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with other products containing diphenhydramine, including any used externally in children under 12 years of age ask a doctor ask a doctor before using this product if, the stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have difficulty in urination due to enlargement of the prostate gland you have liver disease you have high blood pressure, heart disease, liver cirrhosis or kidney disease you have glaucoma you are taking a diuretic you have asthma you have a breathing problem such as emphysema or chronic bronchitis ask a doctor or a pharmacist ask a doctor or pharmacist before using this product if you are taking the following, a prescription drug for: + arthritis + diabetes + gout sedatives or tranquilizers any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer any other drug, or are under a doctor's care for any serious condition when using this product, do not drive a motor vehicle or operate machinery drowsiness may occur avoid alcoholic beverages stop use and ask a doctor stop use of this product and ask a doctor in the event of the following, if an allergic reaction occurs. seek medical help right away. you experience any of signs of stomach bleeding, such as + feeling faint + vomit blood + have bloody or black stools + have stomach pain that does not get better new symptoms occur redness or swelling is present ringing in the ears or loss of hearing occurs your pain gets worse or lasts for more than 10 days sleeplessness persists continuously for more than 2 weeks. insomnia may be a symptom of a serious underlying medical illness. these could be signs of a serious condition pregnancy and nursing mothers if pregnant or breast-feeding ask a health professional before use. it is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. keep out of reach of children in case of an overdose, seek medical help right away or contact a poison control center (1-800-222-1222) immediately. prompt 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 drive a motor vehicle or operate machinery drowsiness may occur avoid alcoholic beverages
Dosage and Administration:
Dosage and administration (directions) adults and children 12 years of age and over: take up to 2 caplets at bedtime, with a full glass of water. do not take more than directed do not take more than 2 caplets in 24 hours, unless directed by a doctor do not use in children under 12 years of age
Stop Use:
Stop use and ask a doctor stop use of this product and ask a doctor in the event of the following, if an allergic reaction occurs. seek medical help right away. you experience any of signs of stomach bleeding, such as + feeling faint + vomit blood + have bloody or black stools + have stomach pain that does not get better new symptoms occur redness or swelling is present ringing in the ears or loss of hearing occurs your pain gets worse or lasts for more than 10 days sleeplessness persists continuously for more than 2 weeks. insomnia may be a symptom of a serious underlying medical illness. these could be signs of a serious condition
Package Label Principal Display Panel:
Principal display panel sunascen therapeutics llc ndc 49467-230-10 mygrin nighttime acetaminophen, 250 mg aspirin (nsaid), 250 mg diphenhydramine citrate, 38 mg pain reliever and sleep-aid non-habit forming "helping you turn the face of pain into a grin" ⢠100 caplets tamper evident: do not use if the safety seal under cap is broken or missing distributed by: sunascen therapeutics llc, rockville md 20850 © 2018 sunascen therapeutics llc, all rights reserved. trademarks are owned by or licensed to sunascen therapeutics llc sunascen therapeutics llc quality guaranteed please recycle st230
Further Questions:
Questions or comments? sunascen therapeutics llc call us toll free at 1-833-sunascn (786-2726) mon-fri 9am-5pm est. email us at consumercare@sunascen.com more information is available on our website at www.sunascen.com