FDA Label for Menstrual Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (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
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PRODUCT LABEL
Menstrual Relief Product Label
The following document was submitted to the FDA by the labeler of this product Top Care (topco Associates 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.
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
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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
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 25°C (77°F) excursions permitted between 15°C-30°C (59°-86° 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
MAXIMUM STRENGTH
Menstrual Relief Caplets
ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE
Pain Reliever / Diuretic / Antihistamine
Multi-Symptom Relief of:
- Cramps
- Bloating
- Fatigue
- Backache & Headache
Caplets
SUPPORTING THE FIGHT AGAINST BREAST CANCER†
Compare to Midol® Complete active ingredients*
*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
Product Label
TopCare Menstrual Relief Caplets
* Please review the disclaimer below.