Mantra Menstrual Pain Gel Strawberry Gel
FDA Label NDC 85410-060

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Moremed Inc. for the product Mantra Menstrual Pain Gel Strawberry (NDC 85410-060). 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 active ingredient (in each 0.85 oz pouch)              purpose, uses, warnings, directions, other information, inactive ingredients, questions or comments?, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 0.85 Oz Pouch)              Purpose

Acetaminophen 500 mg                                           Pain reliever

Pamabrom 25 mg                                                   Diuretic

Uses

For the temporary relief of minor aches and pains and temporary water-weight gain, bloating, swelling, and full feeling associated with the premenstrual and menstrual periods.

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 (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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 are allergic to acetaminophen or pamabrom
    •with any other product containing a diuretic 

    Ask a doctor before use if you have
    •liver disease
    •kidney disease
    •heart disease
    •high blood pressure
    •difficulty urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are
    •taking the blood thinning drug warfarin

    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
    •painful condition persists or gets worse

    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 for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • Do not exceed 2 Pouches in 24 hours unless directed by a doctor.
  • Adults and children 12 years and over: take 1 Pouch with every 12 hours as needed.
  • Do not use for more than 10 days, unless directed by a doctor.
  • Children under 12 years: do not use.

Other Information

  • Store at controlled room temperature 
  • Avoid excessive heat above 40°C (104°F). 
  • Protect from moisture.

Inactive Ingredients

Ascorbic Acid, Citric Acid, Glycerin, Manuka Honey, Natural strawberry Flavor, Pectin, Purified Water, Sodium Citrate

Questions Or Comments?

Call 1-800-529-3182 (toll-free)

Mon–Fri 9 AM–5 PM EST

Product Label

Image Description (Image 1)

Image Description (Image 1)

Image Description (Image 2)

Image Description (Image 2)

* Please review the disclaimer below.