FDA Label for Midol
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH CAPLET)
- PURPOSE
- USES
- WARNINGS
- ALLERGY ALERT:
- 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
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PACKAGE LABEL
Midol Product Label
The following document was submitted to the FDA by the labeler of this product Savings Distributors 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 Ingredients (In Each Caplet)
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
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
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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 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?
1-800-331-4536 (Mon-Fri 9AM - 5PM EST) or www.midol.com
Package Label
* Please review the disclaimer below.