FDA Label for Menstrual Complete
View Indications, Usage & Precautions
Menstrual Complete Product Label
The following document was submitted to the FDA by the labeler of this product Pioneer Life Sciences, 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 Ingredient
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
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 caplets 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
- skin reddening
- blister
- rash
- hives
- facial swelling
- asthma (wheezing)
- shock if a skin or general allergic reaction ocurs, stop use and seek medical help right away.
Allergy alert:
Acetaminophen may cause sever skin or sever allergy reactions. Symptoms may include:
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 Doctor:
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 Doctor/Pharmacist:
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 about as much caffeine as a cup of coffee.
Pregnancy
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children
Overdose Warning: Taking more than directed can cause serious health problems. 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 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 exceed 6 caplets per day
children under 12 years: consult a doctor
Other Information
store at room temperature
Inactive Ingredients
carnauba wax, croscarmellose sodium, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, titanium dioxide, triacetin
Questions Or Comments?
Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com
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
* Please review the disclaimer below.