Active Ingredients (In Each Caplet)
Acetaminophen 500 mg
Pamabrom 25 mg
Pyrilamine maleate 15 mg
Menstrual Relief Tablet, Film Coated
FDA Label NDC 36800-979
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates, Llc for the product Menstrual Relief (NDC 36800-979). 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:
- cramps
- headache
- bloating
- backache
- water-weight gain
- irritability
- muscular 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
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
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 beverages
- excitability may occur, especially in children
- alcohol, sedatives and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
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 directed
- adults and children 12 years and over:
- take 2 caplets with water every 6 hours as needed
- do not exceed 6 caplets in a 24 hour period or as directed by a doctor
- children under 12 years: ask a doctor
Other Information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
corn starch, croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, shellac wax, silicon dioxide, stearic acid, talc, titanium dioxide
Questions Or Comments?
1-888-423-0139
Principal Display Panel
TopCare
health®
NDC 36800-979-10
COMPARE TO MAXIMUM STRENGTH PAMPRIN® MULTI-SYMPTOM ACTIVE INGREDIENTS*
MAXIMUM STRENGTH
Menstrual Relief
ACETAMINOPHEN - PAIN RELIEVER • PAMABROM - DIURETIC
• PYRILAMINE MALEATE - ANTIHISTAMINE
MULTI-SYMPTOM RELIEF OF: Cramps
• Bloating • Irritability • Headache • Backache
OUR PHARMACISTS
RECOMMEND
40 CAPLETS
actual
size
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007 ©TOPCO LNKA0220
QUESTIONS? 1-888-423-0139
[email protected] www.topcarebrand.com
QUALITY
GUARANTEED
*This product is not manufactured or distributed by Focus Consumer Healthcare, LLC, owner of the registered trademark Maximum Strength Pamprin® Multi-Symptom.
50844 REV0718A67910
Topcare 44-679 (Topcare 44 679 1)
* Please review the disclaimer below.
