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  5. Label Information: Menstrual Complete

FDA Label for Menstrual Complete

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSE
    3. ACTIVE INGREDIENTS (IN EACH CAPLET)
    4. USES
    5. WARNINGS
    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. IF PREGNANT OR BREAST-FEEDING
    12. KEEP OUT OF REACH OF CHILDREN
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS OR COMMENTS?
    17. MAXIMUM STRENGTH MENSTRUAL COMPLETE

Menstrual Complete Product Label

The following document was submitted to the FDA by the labeler of this product Health Pharma Usa Llc. 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.

Drug Facts



Maximum Strength Menstrual Complete


Purpose



Pain Reliever, Diuretic, Antihistamine, Multi-Symptom Relief


Active Ingredients (In Each Caplet)



Acetaminophen 500mg

Caffeine 60mg 

Pyrilamine maleate 15mg 


Uses



  • For the temporary relief of these symptoms associated with menstrual periods
  • Cramps 
  • Bloating
  • Water- weight gain
  • Headache
  • Backache
  • Muscle aches
  • Fatigue

Warnings



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 warning: 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 aboout as much caffeine as a cup of coffee.

Stop Use And Ask A Doctor If



  • new symptoms appear
  • 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

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 (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 exceed recommended dosage.
  • 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
  • TAMPER EVIDENT; DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive Ingredients



Microcrystalline cellulose

Pregelatinized starch

Stearic Acid

Colloidal Silicon Dioxide

Magnesium Stearate

Hydroxy propyl methyl cellulose

Polyethylene glycol

Titanium dioxide

PVP-K30

Sodium starch glycolate


Questions Or Comments?



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