Midol Complete
Acetaminophen, Caffeine, and Pyrilamine Maleate · Tablet · Oral
Active ingredient
Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever Caffeine 60 mg Diuretic Pyrilamine maleate 15 mg Antihistamine
Purpose
Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever Caffeine 60 mg Diuretic Pyrilamine maleate 15 mg Antihistamine
Uses
Uses for the temporary relief of these symptoms associated with menstrual periods: cramps bloating water-weight gain headache backache muscle aches fatigue
Warnings
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.
Do not use
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
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
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers
When using this product
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
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
Pregnancy or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
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
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
Other information Store at room temperature. Avoid excessive heat above 40°C (104°F).
Inactive ingredients
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?
Questions or comments? 1-800-331-4536 (Mon-Fri 9AM-5PM EST)
Label text from the FDA structured product label by Lil' Drug Store Products, Inc (revised Dec 10, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acetaminophen in 7 products
- Caffeine in 7 products
- Pyrilamine Maleate in 7 products
Midol Complete NDC products (7)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0924-6010 | Acetaminophen 500 mg/1; Caffeine 60 mg/1; Pyrilamine Maleate 15 mg/1 Tablet | Acme United Corporation | OTC MONOGRAPH DRUG |
| 0280-8015 | Caffeine 60 mg/1; Pyrilamine Maleate 15 mg/1; Acetaminophen 500 mg/1 Tablet, Coated | Bayer HealthCare LLC | OTC MONOGRAPH DRUG |
| 0280-8005 | Acetaminophen 500 mg/1; Caffeine 60 mg/1; Pyrilamine Maleate 15 mg/1 Tablet | Bayer HealthCare LLC. | OTC MONOGRAPH DRUG |
| 66715-9745 | Acetaminophen 500 mg/1; Caffeine 60 mg/1; Pyrilamine Maleate 15 mg/1 Tablet | Lil' Drug Store Products, Inc | OTC MONOGRAPH DRUG |
| 29485-7964 | Acetaminophen 500 mg/1; Caffeine 60 mg/1; Pyrilamine Maleate 15 mg/1 Tablet | Lil' Drug Store Products, Inc. | OTC MONOGRAPH DRUG |
| 70264-012 | Pyrilamine Maleate 15 mg/1; Acetaminophen 500 mg/1; Caffeine 60 mg/1 Tablet | R J General Corporation | OTC MONOGRAPH DRUG |
| 85237-1841 | Acetaminophen 500 mg/1; Caffeine 60 mg/1; Pyrilamine Maleate 15 mg/1 Tablet | Select Consumer Group | OTC MONOGRAPH DRUG |
Midol Complete recalls
- D-1423-2012 Jul 25, 2012 · Class III · Terminated
Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not… - D-1424-2012 Jul 25, 2012 · Class III · Terminated
Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not…
Frequently asked questions
What is Midol Complete used for?
Uses for the temporary relief of these symptoms associated with menstrual periods: cramps bloating water-weight gain headache backache muscle aches fatigue
Who makes Midol Complete?
Midol Complete is listed by 7 labelers in the FDA NDC directory, including Acme United Corporation, Bayer HealthCare LLC, Bayer HealthCare LLC., Lil' Drug Store Products, Inc.
Has Midol Complete been recalled?
The FDA enforcement database lists 2 recalls for Midol Complete, most recently D-1423-2012 (class iii): Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of…