Midol Complete Gelcaps
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each gelcap) Purpose
Acetaminophen 500 mg..............................………………….Pain reliever
Caffeine 60 mg……….…………………………………….……..….Diuretic
Pyrilamine maleate 15 mg……………………………………Antihistamine
Purpose
INDICATIONS & USAGE SECTION
Uses for the temporary relief of these symptoms associated with menstrual periods:
- cramps
- bloating
- water-weight gain
- headache
- backache
- muscle ache
- fatigue
WARNINGS SECTION
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
· more than 6 gelcaps 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
Allergy Alert: acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:
· skin reddening · blisters · rash
· hives · facial swelling · asthma (wheezing) · shock
If a skin or general allergic reaction occurs, stop use and seek medical help right away.
OTC - DO NOT USE SECTION
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
OTC - ASK DOCTOR SECTION
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
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are · taking the blood thinning drug warfarin · taking sedatives or tranquilizers
OTC - WHEN USING SECTION
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.
OTC - STOP USE SECTION
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 for adults as well as for children even if you do not notice any signs or symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions
· do not take more than the recommended dose
· adults and children 12 years and older:
· take 2 gelcaps with water
· repeat every 6 hours, as needed
· do not exceed 6 gelcaps per day
· children under 12 years: consult a doctor
OTHER SAFETY INFORMATION
Other information
· store at room temperature
· avoid excessive heat 104°F (40°C)
INACTIVE INGREDIENT SECTION
Inactive ingredients black iron oxide, carnauba wax, croscarmellose sodium, D&C red #33 aluminum lake, edetate disodium, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose, lecithin, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, simethicone, stearic acid, titanium dioxide, triacetin
OTC - QUESTIONS SECTION
Questions or comments? 1-800-331-4536 (Mon-Fri 9AM - 5PM EST)