1. Home
  2. Labeler Index
  3. We Care Distributor Inc.
  4. 70005-011
  5. Label Information: Menstrual Relief

FDA Label for Menstrual Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. LIVER WARNING:
    5. ALLERGY ALERT:
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    9. WHEN USING THIS PRODUCT
    10. STOP USE AND ASK A DOCTOR IF
    11. OTC - PREGNANCY OR BREAST FEEDING
    12. OTC - KEEP OUT OF REACH OF CHILDREN
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS OR COMMENTS?
    17. PRINCIPAL DISPLAY PANEL

Menstrual Relief Product Label

The following document was submitted to the FDA by the labeler of this product We Care Distributor Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Otc - Purpose



 
 Active Ingredient (in each tablet) Purpose
 Acetaminophen 500 mg Pain reliever
 Caffeine 60 mg Diuretic
 Pyrilamine Maleate 15 mg Antihistamine

 


Uses



for the temporary relief of these symptoms associated with menstrual periods:

  • cramps 
  • bloating
  • water-weight gain
  • headache 
  • backache 
  • muscle aches
  • fatigue

Liver Warning:



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

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

Allergy Alert:



acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

  • skin reddening 
  • blisters
  • rash
  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

    • If a skin or general allergic 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 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 about as much caffeine as a cup of coffee.

Stop Use And Ask A Doctor If



    • any new symptoms occur
    • redness or swelling is present
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days

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 (1-800-222-1222) 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 over: take 2 tablets with water. Repeat every 6 hours, as needed; do not exceed 6 tablets per day
  • children under 12 years: consult a doctor

Other Information



  • store at room temperature

  • read all product information before using. Keep this box for important information

Inactive Ingredients



colloidal silicon dioxide, hypromellse, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl pyrrolodine, pregelatinized starch, titanium dioxide, talc


Questions Or Comments?



1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com


Principal Display Panel



See New Warnings Information & Directions

Compare to the Active Ingredients in
Midol Complete

Acetaminophen, Caffeine and Pyrilamine Maleate Tablets, 500 mg, 60 mg and 15 mg

TO OPEN
PUSH IN TAB AND PULL OUT

25 Pouches of 2 Tablets Each


* Please review the disclaimer below.