Menstrual Relief
FDA Label NDC 76168-064

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Velocity Pharma for the product Menstrual Relief (NDC 76168-064). 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, purpose, uses, warnings, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

SEE BOTTLE FOR ADDITIONAL WARNINGS AND PRODUCT INFORMATION.

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • More than 6 caplets in 24 hours, which is the maximum daily amount for this product
  • With other drug containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

    • 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:

      • Liver disease
      • Glaucoma
      • Difficulty in urination due to enlargement of the prostate gland
      • A breathing problem such as emphysema or chronic bronchitis

        • Ask a doctor or pharmacist before use if you are:

        • Taking 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 as a cup of coffee.

          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

          • 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 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: ask a doctor.

Other Information

  • Store at a controlled temperature between 62 and 77 degrees F

Inactive Ingredients

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

Questions?

Call 1-855-314-1850

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: Velocity Pharma LLC

Package Label.Principal Display Panel

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NDC: 76168-064-03 –20 COUNT

Enteric Coated to help prevent upset stomach

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