Mantra Pain Gel Raspberry Gel
FDA Label NDC 85410-050

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 Pain Gel Raspberry (NDC 85410-050). 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

Uses

Temporarily relieves minor aches and pains due to:

  • headache 
  • minor pain of arthritis 
  • backache 
  • the common cold 
  • temporarily reduces fever 
  • muscular aches 
  • premenstrual and menstrual cramps 
  • toothache

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.

Directions

  • Do not exceed 2 pouches in 24 hours unless directed by a doctor.
  • Adults and children 12 years and over: take 1 pouch every 12 hours while symptoms last.
  • 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 Raspberry 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.