Menstrual Relief Maximum Strength
Acetaminophen, Pamabrom, Pyrilamine Maleate
L.n.k. International, Inc.
Human Otc Drug
NDC 50844-679Menstrual Relief Maximum Strength also known as Acetaminophen, Pamabrom, Pyrilamine Maleate is a human otc drug labeled by 'L.n.k. International, Inc.'. National Drug Code (NDC) number for Menstrual Relief Maximum Strength is 50844-679. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Menstrual Relief Maximum Strength drug includes Acetaminophen - 500 mg/1 Pamabrom - 25 mg/1 Pyrilamine Maleate - 15 mg/1 . The currest status of Menstrual Relief Maximum Strength drug is Active.
Drug Information:
| Drug NDC: | 50844-679 |
| 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 Maximum Strength |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Menstrual Relief |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Maximum Strength |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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, Pamabrom, Pyrilamine Maleate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | L.n.k. International, Inc. |
| 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 - 500 mg/1
PAMABROM - 25 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: | 13 Jan, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 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: | 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: | L.N.K. International, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1052637
|
| 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: | 0350844679277
|
| UPC stands for Universal Product Code. |
| UNII: | 362O9ITL9D
UA8U0KJM72
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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 50844-679-27 | 1 BOTTLE in 1 CARTON (50844-679-27) / 32 TABLET, FILM COATED in 1 BOTTLE | 13 Jan, 2015 | 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 maximum strength acetaminophen, pamabrom, pyrilamine maleate acetaminophen acetaminophen pamabrom bromotheophylline pyrilamine maleate pyrilamine starch, corn croscarmellose sodium crospovidone fd&c blue no. 2--aluminum lake fd&c red no. 40 magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified povidone, unspecified shellac silicon dioxide stearic acid talc titanium dioxide 44;679
Indications and Usage:
Uses for the temporary relief of these symptoms associated with menstrual periods: headache bloating cramps backache muscular aches irritability water-weight gain
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 difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis liver disease glaucoma ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug wa
Read more...rfarin when using this product drowsiness may occur avoid alcoholic beverages excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present 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 accidental overdose, get medical help or contact a poison control center right away. 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 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 difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis liver disease glaucoma ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin when using this product drowsiness may occur avoid alcoholic beverages excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present 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 accidental overdose, get medical help or contact a poison control center right away. 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 drowsiness may occur avoid alcoholic beverages excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery
Dosage and Administration:
Directions do not take more than directed adults and children 12 years and over: take 2 caplets with water every 6 hours as needed do not exceed 6 caplets in a 24 hour period or as directed by a doctor children under 12 years: ask a doctor
Stop Use:
Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel quality +plus ndc 50844-679-27 *compare to active ingredients in maximum strength pamprin® multi-symptom maximum strength menstrual relief pain reliever, diuretic, antihistamine acetaminophen, pamabrom, pyrilamine maleate aspirin/caffeine free multi-symptom 32 caplets actual size *this product is not manufactured or distributed by focus consumer healthcare, llc, owner of the registered trademark maximum strength pamprin® multi-symptom. 50844 rev0718a67927 distributed by lnk international, inc. 60 arkay drive hauppauge, ny 11788 usa tamper evident: do not use if imprinted safety seal under cap is broken or missing quality plus 44-679 quality plus 44-679
Further Questions:
Questions or comments? 1-800-426-9391