Equate Menstrual Pain Relief Tablet, Film Coated, Extended Release
FDA Label NDC 79903-420

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walmart Inc. for the product Equate Menstrual Pain Relief (NDC 79903-420). 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 caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient (In Each Caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

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
  • 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

    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 any of the inactive ingredients in this product

Ask A Doctor Before Use If You Have

liver disease

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
  • redness or swelling is present

    These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 directed (see overdose warning)
  • adultsunder 18 years of age
     
    • take 2 caplets every 8 hours with water
    • swallow whole; do not crush, chew, split or dissolve
    • do not take more than 6 caplets in 24 hours
    • do not use for more than 10 days unless directed by a doctor
     
    • ask a doctor

Other Information

  • store at 20-25°C (68-77°F)
  • do not use if printed foil under cap is broken or missing
  • meets the requirements of USP Dissolution Test 4

Inactive Ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions Or Comments?

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Package/Label Principal Display Panel

equate™

Compare to Midol® Long Lasting Relief active ingredient

Menstrual Pain Relief

Acetaminophen

Extended-Release Tablets, 650 mg

PUSH & TURN CAP

Pain Reliever/Fever Reducer

650 mg EACH

For up to 8 Hours

Relief of Minor Muscle Aches and Pain

20 CAPLETS*

Actual Size

*Capsule-Shaped Tablets

Equate-menstrual-pain-relief-carton-image.jpg (Equate Menstrual Pain Relief Carton Image)

Equate-menstrual-pain-relief-carton-image.jpg (Equate Menstrual Pain Relief Carton Image)

* Please review the disclaimer below.