NDC 72090-026 Menstrual Complete

Acetaminophen, Caffeine, Pyrilamine Maleate

NDC Product Code 72090-026

NDC 72090-026-02

Package Description: 40 TABLET in 1 BOTTLE

NDC Product Information

Menstrual Complete with NDC 72090-026 is a a human over the counter drug product labeled by Pioneer Life Sciences, Llc. The generic name of Menstrual Complete is acetaminophen, caffeine, pyrilamine maleate. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Pioneer Life Sciences, Llc

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Menstrual Complete Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CAFFEINE 60 mg/1
  • PYRILAMINE MALEATE 15 mg/1
  • ACETAMINOPHEN 500 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • TRIACETIN (UNII: XHX3C3X673)
  • SHELLAC (UNII: 46N107B71O)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Pioneer Life Sciences, Llc
Labeler Code: 72090
FDA Application Number: part343 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 07-17-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Menstrual Complete Product Label Images

Menstrual Complete Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Acetaminophen 500 mg

Caffeine 60 mg

Pyrilamine maleate 15 mg

Purpose

Pain reliever,Diuretic, Antihistamine

Uses:

For the temporary relief of these symptoms associated with menstrual periods:cramps

bloating

water-weight gain

headache

backache

muscle aches

fatigue

Warnings:

  • Liver warningThis product contains acetaminophen. Severe liver damage may occur if you takemore than 6 caplets in 24 hours, which is the maximum daily amount for this productwith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this productAllergy alert:Acetaminophen may cause sever skin or sever allergy reactions. Symptoms may include:skin reddeningblisterrashhivesfacial swellingasthma (wheezing)shock if a skin or general allergic reaction ocurs, 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 Doctor:

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 Doctor/Pharmacist:

Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin

taking sedatives or tranquilizers

When Using This Product

You may get drowsy

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.

Pregnancy

If pregnant or breast-feeding, ask a health 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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 exceed 6 caplets per day
children under 12 years: consult a doctor

Other Information

Store at room temperature

Inactive Ingredients

Carnauba wax, croscarmellose sodium, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, titanium dioxide, triacetin

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 lasts more than 3 days

* Please review the disclaimer below.