Active Ingredients (In Each Caplet)
Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine maleate 15 mg
Menstrual Relief Tablet, Film Coated
FDA Label NDC 50804-990
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geiss, Destin & Dunn Inc. for the product Menstrual Relief (NDC 50804-990). 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 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever
Diuretic
Antihistamine
Uses
for the temporary relief of these symptoms associated with menstrual periods:
- bloating
- headache
- water-weight gain
- cramps
- backache
- fatigue
- 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
- difficulty in urination due to enlargement of the prostate gland
- liver disease
- glaucoma
- 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
- avoid alcoholic beverages
- excitability may occur, especially in children
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
- you may get drowsy
- limit the use of caffeine-containing medications, foods, or beverages while taking this product 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 lasts 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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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 caplets with water
- repeat every 6 hours, as needed
- do not exceed 6 caplets per day
- children under 12 years: ask a doctor
Other Information
- see end flap for expiration date and lot number
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients
corn starch, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin
Questions Or Comments?
1-800-426-9391
Principal Display Panel
GoodSense®
NDC 50804-990-08
Menstrual
Relief Caplets
Acetaminophen, Caffeine,
Pyrilamine maleate
• Pain Reliever • Diuretic • Antihistamine
Maximum Strength
Multi-Symptom Relief of:
• Cramps • Bloating • Fatigue
• Backache • Headache
*Compare to the active ingredients of
Midol® Complete
24 Caplets
actual size
100%
SATISFACTION
GUARANTEED
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Bayer
HealthCare LLC, owner of the registered trademark Midol®
Complete. 50844 ORG051739008
Distributed by: Geiss, Destin & Dunn, Inc., A Perrigo Company
Peachtree City, GA 30269
www.PerrigoDirect.com
(1-800-426-9391)
GoodSense® is a registered trademark of L. Perrigo Company.
Goodsense 44-390 (Goodsense 44 390 1)
* Please review the disclaimer below.
