Indications and uses
for the temporary relief of these symptoms associated with menstrual periods: ● cramps ●bloating ●water-weight gain ●headache ●backache ●muscle aches ●fatigue
for the temporary relief of these symptoms associated with menstrual periods: ● cramps ●bloating ●water-weight gain ●headache ●backache ●muscle aches ●fatigue
● 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
Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine maleate 15 mg
Pain reliever
Diuretic
Antihistamine
for the temporary relief of these symptoms associated with menstrual periods:
● cramps ●bloating ●water-weight gain ●headache
●backache ●muscle aches ●fatigue
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
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.
● 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
● liver disease
● glaucoma
● difficulty in urination due to enlargement of the prostate gland
● a breathing problem such as emphysema or chronic bronchitis
● taking the blood thinning drug warfarin
● taking sedatives or tranquilizers
● 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.
● 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
ask a health professional before use.
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 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
store at room temperature
carnauba wax, croscarmellose sodium, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, titanium dioxide, triacetin
1-800-331-4536 (Mon-Fri 9AM - 5PM EST) or
www.midol.com
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1597298 | acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral Tablet | PSN | 1 |
| 1597298 | acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral Tablet | SCD | 1 |
| 1597298 | APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral Tablet | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7dea7767-9f52-b60a-5435-33cb9cc28bae | Product name | 4 | 20250124 |
| 6338270f-96cb-0ecb-6fbb-0a9bc78001f4 | Product name | 7 | 20250116 |
| 0ca83774-3f79-b837-5d6f-c210102f3bc8 | Product name | 6 | 20250114 |
| 41b814f3-0166-1c53-c9ef-a0794c7daf9d | Product name | 3 | 20221110 |
| a590be26-846c-8659-a5a1-fb25907965dc | Product name | 2 | 20221110 |
| 2dc76302-91c0-4c35-ad78-99adfb049c4b | Product name | 1 | 20200603 |
| e6065d4b-5ae1-476f-a40e-f2851cbb5d2b | Product name | 2 | 20180221 |
| f212291f-05fe-9603-fc7e-bd73e38ce1e6 | Product name | 2 | 20161129 |
| 182f9ab4-4ab5-c449-200f-87ce2ce8e550 | Product name | 2 | 20151105 |
| 332e86c3-7875-ca6e-f934-2206d2b31996 | Product name | 1 | 20140508 |
| 56625fcc-aa34-9d30-d0e9-1c1beb37ea21 | Product name | 1 | 20140508 |
| 7dfac40f-a405-cd2e-7c06-3059ec0e1092 | Product name | 1 | 20140508 |
| 96c2be53-8e44-452d-56a2-d255b2f1af2d | Product name | 1 | 20140508 |
| bf8bd5f7-495f-4022-2780-7ded7ea7ea44 | Product name | 1 | 20140508 |
| d223c173-c39b-d764-47d4-d671d3088815 | Product name | 1 | 20140508 |
| e01133ad-4dcd-c7f3-454b-2ff569ee160a | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 73097-007-02 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-45d5-a910-e053-dadaa90a0b85 | Midol |
| 73097-007-40 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-45d5-a910-e053-dadaa90a0b85 | Midol |
| 73097-007-50 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-45d5-a910-e053-dadaa90a0b85 | Midol |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 73097-007-02 | Midol | 1 in 1 CARTON | TABLET | 1 | 1 | |
| 73097-007-02 | Midol | 2 in 1 POUCH | TABLET | 2 | 1 | |
| 73097-007-40 | Midol | 20 in 1 CARTON | TABLET | 20 | 1 | |
| 73097-007-40 | Midol | 2 in 1 POUCH | TABLET | 2 | 1 | |
| 73097-007-50 | Midol | 25 in 1 CARTON | TABLET | 25 | 1 | |
| 73097-007-50 | Midol | 2 in 1 POUCH | TABLET | 2 | 1 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0280-8005-16 | EA - Each | 0280-8005 | dcbec074-9880-48e9-96d8-049649c185be | 1 | 2018-04-19 |
| 0280-8005-24 | EA - Each | 0280-8005 | eaea4dec-a037-41d2-b348-b5491e1f1199 | 1 | 2018-04-19 |
| 0280-8005-40 | EA - Each | 0280-8005 | 7092f7e0-408c-4e14-a65c-d4ba66cb33dd | 1 | 2016-02-04 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 73097-007 | 73097-007-02, 73097-007-40, 73097-007-50 |
| 0280-8005 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| FD&C BLUE NO. 2 | L06K8R7DQK | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SHELLAC | 46N107B71O | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| TRIACETIN | XHX3C3X673 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| CAFFEINE | 3G6A5W338E | ACTIB |
| PYRILAMINE MALEATE | R35D29L3ZA | ACTIB |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Midol Complete | ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE | Bayer HealthCare LLC. | ce9e6acb-a38b-4c9b-a7e8-3e1c2a49a324 | 2025-04-10 | Warnings | 0280-8005 |
| 8d6ed3ad-fd3f-47f3-e053-2995a90aba28 | 8d6edcac-504b-d437-e053-2995a90a6b7a | 2019-07-11 | Warnings | 8d6ed3ad-fd3f-47f3-e053-2995a90aba28 8d6edcac-504b-d437-e053-2995a90a6b7a |
Adverse event summaries are temporarily unavailable. Other product information remains available.