Menstrual Relief
Acetaminophen, Caffeine And Pyrilamine Maleate
Top Care (topco Associates Llc)
Human Otc Drug
NDC 36800-187Menstrual Relief also known as Acetaminophen, Caffeine And Pyrilamine Maleate is a human otc drug labeled by 'Top Care (topco Associates Llc)'. National Drug Code (NDC) number for Menstrual Relief is 36800-187. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Menstrual Relief drug includes Acetaminophen - 500 mg/1 Caffeine - 60 mg/1 Pyrilamine Maleate - 15 mg/1 . The currest status of Menstrual Relief drug is Active.
Drug Information:
| Drug NDC: | 36800-187 |
| 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: | Menstrual Relief |
| 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, Caffeine And Pyrilamine Maleate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Top Care (topco Associates Llc) |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| 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 - 500 mg/1
CAFFEINE - 60 mg/1
PYRILAMINE MALEATE - 15 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: | 31 Mar, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 05 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: | 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, 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: | TOP CARE (Topco Associates LLC)
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1597298
|
| 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: | 0036800138308
|
| UPC stands for Universal Product Code. |
| NUI: | N0000175739
N0000175729
N0000175790
M0023046
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 362O9ITL9D
3G6A5W338E
R35D29L3ZA
|
| 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 EPC: | Central Nervous System Stimulant [EPC]
Methylxanthine [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: | Central Nervous System Stimulation [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: | Xanthines [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: | Central Nervous System Stimulant [EPC]
Central Nervous System Stimulation [PE]
Methylxanthine [EPC]
Xanthines [CS]
|
| 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 |
|---|
| 36800-187-24 | 24 BLISTER PACK in 1 CARTON (36800-187-24) / 1 TABLET in 1 BLISTER PACK | 31 Mar, 2014 | 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 diuretic antihistamine
Product Elements:
Menstrual relief acetaminophen, caffeine and pyrilamine maleate acetaminophen acetaminophen caffeine caffeine pyrilamine maleate pyrilamine silicon dioxide croscarmellose sodium crospovidone hypromelloses magnesium stearate cellulose, microcrystalline mineral oil povidone starch, corn stearic acid titanium dioxide tcl347
Indications and Usage:
Uses for the temporary relief of these symptoms associated with menstrual periods cramps bloating fatigue backache water-weight gain headache muscle aches
Warnings:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours 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. 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 have ever had an allergic reaction to this product or any of its ingredients ask a doctor before use if you have liver disease glaucoma difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranq
Read more...uilizers when using this product drowsiness may occur avoid alcoholic drinks excitability may occur, especially in children alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. the recommended dose of this product contains about as much caffeine as a cup of coffee. stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or last more than 3 days 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. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical 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 4,000 mg of acetaminophen in 24 hours 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. 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 have ever had an allergic reaction to this product or any of its ingredients ask a doctor before use if you have liver disease glaucoma difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers when using this product drowsiness may occur avoid alcoholic drinks excitability may occur, especially in children alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. the recommended dose of this product contains about as much caffeine as a cup of coffee. stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or last more than 3 days 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. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical even if you do not notice any signs or symptoms.
When Using:
When using this product drowsiness may occur avoid alcoholic drinks excitability may occur, especially in children alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. the recommended dose of this product contains about as much caffeine as a cup of coffee.
Dosage and Administration:
Directions do not take more than the recommended dose adults and children 12 years and older take 2 caplets with water repeat every 6 hours, as needed do not take more than 6 caplets in 24 hours children under 12 years: consult a doctor
Stop Use:
Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or last more than 3 days these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel compare to midol® complete active ingredients* maximum strength supporting the fight against breast cancerâ menstrual relief acetaminophen , caffeine, pyrilamine maleate pain reliever ⢠diuretic ⢠antihistamine multi-symptom relief of: cramps bloating fatigue backache headache caplets *this product is not manufactured or distributed by bayer healthcare llc, distributor of midol® complete. tamper evident: do not use if carton is opened or if blister unit is torn, broken or shows any signs of tampering. keep outer carton for complete warnings and product information. distributed by: topco associates llc elk grove village, il 60007 ©topco questions? 1-888-423-0139 topcare@topcare.com
Product label topcare health menstrual relief acetaminophen 500 mg, caffeine 60 mg, pyrilamine maleate 15 mg
Further Questions:
Questions or comments? call toll free 1-888-423-0139