Midol Complete Gelcaps
0a4477ce-0a02-197d-e054-00144ff88e88
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredients (in each gelcap) Purpose Acetaminophen 500 mg..............................………………….Pain reliever Caffeine 60 mg……….…………………………………….……..….Diuretic Pyrilamine maleate 15 mg……………………………………Antihistamine
Medication Information
Warnings and Precautions
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.
Indications and Usage
Uses for the temporary relief of these symptoms associated with menstrual periods:
- cramps
- bloating
- water-weight gain
- headache
- backache
- muscle ache
- fatigue
Dosage and Administration
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
Description
Active ingredients (in each gelcap) Purpose Acetaminophen 500 mg..............................………………….Pain reliever Caffeine 60 mg……….…………………………………….……..….Diuretic Pyrilamine maleate 15 mg……………………………………Antihistamine
Section 50565-1
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.
Section 50566-9
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
Section 50567-7
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.
Section 50568-5
Ask a doctor or pharmacist before use if you are
· taking the blood thinning drug warfarin
· taking sedatives or tranquilizers
Section 50569-3
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
Section 50570-1
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
Section 51727-6
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
Section 51945-4
Section 53413-1
Questions or comments? 1-800-331-4536 (Mon-Fri 9AM - 5PM EST)
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Section 55106-9
Active ingredients (in each gelcap) Purpose
Acetaminophen 500 mg..............................………………….Pain reliever
Caffeine 60 mg……….…………………………………….……..….Diuretic
Pyrilamine maleate 15 mg……………………………………Antihistamine
Section 60561-8
Other information
· store at room temperature
· avoid excessive heat 104°F (40°C)
Structured Label Content
Indications and Usage (34067-9)
Uses for the temporary relief of these symptoms associated with menstrual periods:
- cramps
- bloating
- water-weight gain
- headache
- backache
- muscle ache
- fatigue
Dosage and Administration (34068-7)
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
Warnings and Precautions (34071-1)
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.
Section 50565-1 (50565-1)
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.
Section 50566-9 (50566-9)
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
Section 50567-7 (50567-7)
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.
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are
· taking the blood thinning drug warfarin
· taking sedatives or tranquilizers
Section 50569-3 (50569-3)
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
Section 50570-1 (50570-1)
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
Section 51727-6 (51727-6)
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
Section 51945-4 (51945-4)
Section 53413-1 (53413-1)
Questions or comments? 1-800-331-4536 (Mon-Fri 9AM - 5PM EST)
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Section 55106-9 (55106-9)
Active ingredients (in each gelcap) Purpose
Acetaminophen 500 mg..............................………………….Pain reliever
Caffeine 60 mg……….…………………………………….……..….Diuretic
Pyrilamine maleate 15 mg……………………………………Antihistamine
Section 60561-8 (60561-8)
Other information
· store at room temperature
· avoid excessive heat 104°F (40°C)
Advanced Ingredient Data
Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:27.253136 · Updated: 2026-03-14T23:10:55.855807