Menstrual Pain Relief Complete Tablet, Film Coated
FDA Label NDC 83059-0119

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shield Pharmaceuticals Corp for the product Menstrual Pain Relief Complete (NDC 83059-0119). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each caplet), purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779

Active Ingredient (In Each Caplet)

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 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
    • hives
    • facial swelling
    • asthma (wheezing)
    • shock
    • If a skin reaction occurs, stop use and seek medical help right away.

Otc - Do Not Use

Do not use

  • if you have ever had an allergic reaction to this product or any of its ingredients
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Otc - Ask Doctor

Ask a doctor before use if you have

  • difficulty in urination due to enlargement of the prostate gland
  • liver disease _ glaucoma
  • a breathing problem such as emphysema or chronic

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if youare

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Otc - When Using

When using this product

  • avoid alcoholic beverages
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machiner
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • you may get drowsy
  • limit the use of caffeine-containing medications, foods, or beverages while taking this product 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.

Otc - 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 lasts more than 3 days
  • These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding,ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of 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.

Directions

adults and children 12 years and over:

  • do not take more than the recommended dose
  • adults and children 12 years and over: take 2 caplets with water
  • repeat every 6 hours, as needed
  • do not exceed 6 caplets per day
  • children under 12 years: ask a doctor

Other Information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients

calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, FD&C yellow no. 6, hypromellose, isopropyl alcohol, magnesium stearate, methylene chloride, microcrystalline cellulose, polyethylene glycols, polyvinyl pyrrolidone, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid, talc, titanium dioxide
*may contain this ingredient

Questions Or Comments?

1-800-373-6981 (toll-free)

Principal Display Panel

Menstrual Pain Relief Complete


Acetaminophen/Caffeine/Pyrilamine maleate

Pain reliever/Diuretic/Antihistamine

Label

Label-front (Label Front)

Label-front (Label Front)

Label-back (Label Back)

Label-back (Label Back)

* Please review the disclaimer below.