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Menstrual Relief by TOP CARE (Topco Associates LLC)

Medically reviewed on June 19, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg, CAFFEINE 60mg, PYRILAMINE MALEATE 15mg
Labeler: TOP CARE (Topco Associates LLC)
NDC Code: 36800-187

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients (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
    • fatigue
    • backache
    • water-weight gain
    • headache
    • muscle aches

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
  • 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 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
  • drowsiness may occur
  • 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
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or last more than 3 days

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.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical 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 take more than 6 caplets in 24 hours
  • children under 12 years: consult a doctor

Other information
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86º F)

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

Call toll free 1-888-423-0139

Principal Display Panel

COMPARE TO MIDOL® COMPLETE ACTIVE INGREDIENTS*

MAXIMUM STRENGTH SUPPORTING THE FIGHT AGAINST BREAST CANCER†

Menstrual Relief

ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE

PAIN RELIEVER • DIURETIC • ANTIHISTAMINE

MULTI-SYMPTOM RELIEF OF:

  • Cramps
  • Bloating
  • Fatigue
  • Backache 
  • Headache

CAPLETS

*This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Midol® Complete.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007 ©TOPCO

QUESTIONS? 1-888-423-0139

topcare@topcare.com    

Product Label

TOPCARE HEALTH Menstrual Relief

MENSTRUAL RELIEF 
acetaminophen, caffeine and pyrilamine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-187
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
CAFFEINE (CAFFEINE) CAFFEINE60 mg
PYRILAMINE MALEATE (PYRILAMINE) PYRILAMINE MALEATE15 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
CROSPOVIDONE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
POVIDONE 
STARCH, CORN 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize17mm
FlavorImprint CodeTCL347
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-187-2424 BLISTER PACK in 1 CARTON
11 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34303/31/2014
Labeler - TOP CARE (Topco Associates LLC) (006935977)

 
TOP CARE (Topco Associates LLC)

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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