MIDOL COMPLETE GELCAPS- midol complete tablet, coated
Bayer HealthCare LLC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Active ingredients (in each gelcap) Purpose
Acetaminophen 500 mg..............................………………….Pain reliever
Caffeine 60 mg……….…………………………………….……..….Diuretic
Pyrilamine maleate 15 mg……………………………………Antihistamine
Uses for the temporary relief of these symptoms associated with menstrual periods:
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.
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
· 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.
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
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.
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
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
MIDOL COMPLETE
GELCAPS
midol complete tablet, coated |
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Labeler - Bayer HealthCare LLC (112117283) |