Indications and uses
for the temporary relief of these symptoms associated with menstrual periods: cramps bloating water-weight gain headache fatigue backache muscle aches
Midol Complete
- Manufacturer
- Select Corporation
- Effective date
- 2022-04-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:49:15
Label at a glance#
ProductMidol Complete
Active ingredientacetaminophen, caffeine, pyrilamine maleate
Label structure9 sections
Dosage and administration
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
Storage and handling
store at room temperature. Avoid temperatures above 25°C (77°F).
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredients (in each caplet) | 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:
- cramps
- bloating
- water-weight gain
- headache
- fatigue
- backache
- muscle aches
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
SPL UNCLASSIFIED SECTION
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 |
|
| children under 12 years | consult a doctor |
Other information
- store at room temperature. Avoid temperatures above 25°C (77°F).
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 or comments?
1-800-331-4536 (Mon-Fri 9-5 EST)
PRINCIPAL DISPLAY PANEL - 2 Caplet Pouch Blister Pack
Midol®
COMPLETE
Acetaminophen/Caffeine/Pyrilamine Maleate
Pain Reliever/Diuretic/Antihistamine
MULTI-SYMPTOM RELIEF OF
CRAMPS • BLOATING • FATIGUE
HEADACHE • BACKACHE
NEW LOOK
2 Caplets
Single-Pack
DailyMed RxNorm Mappings#
| 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 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52904-841-04 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5f32-111a-e063-dadaa90a10e2 | Midol ® Complete |
| 52904-841-20 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5f32-111a-e063-dadaa90a10e2 | Midol ® Complete |
| 52904-841-25 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5f32-111a-e063-dadaa90a10e2 | Midol ® Complete |
| 52904-841-30 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5f32-111a-e063-dadaa90a10e2 | Midol ® Complete |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52904-841-04 | Midol Complete | 1 in 1 BLISTER PACK | TABLET | 1 | 1 | |
| 52904-841-04 | Midol Complete | 2 in 1 POUCH | TABLET | 2 | 1 | |
| 52904-841-20 | Midol Complete | 20 in 1 CARTON | TABLET | 20 | 1 | |
| 52904-841-20 | Midol Complete | 2 in 1 POUCH | TABLET | 2 | 1 | |
| 52904-841-25 | Midol Complete | 25 in 1 CARTON | TABLET | 25 | 1 | |
| 52904-841-25 | Midol Complete | 2 in 1 POUCH | TABLET | 2 | 1 | |
| 52904-841-30 | Midol Complete | 30 in 1 CARTON | TABLET | 30 | 1 | |
| 52904-841-30 | Midol Complete | 2 in 1 POUCH | TABLET | 2 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| 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 |
Products#
Every source-derived product name is available through these pages.
- Midol Complete
- acetaminophen, caffeine, and pyrilamine maleate
- acetaminophen
- caffeine
- pyrilamine maleate
- pyrilamine
- carnauba wax
- croscarmellose sodium
- FD&C blue no. 2
- HYPROMELLOSE, UNSPECIFIED
- magnesium stearate
- microcrystalline cellulose
- propylene glycol
- shellac
- titanium dioxide
- triacetin
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 52904-841 | 52904-841-04, 52904-841-20, 52904-841-25, 52904-841-30 |
| 0280-8005 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| acetaminophen | 362O9ITL9D | ACTIB |
| caffeine | 3G6A5W338E | ACTIB |
| pyrilamine maleate | R35D29L3ZA | ACTIB |
| carnauba wax | R12CBM0EIZ | IACT |
| croscarmellose sodium | M28OL1HH48 | IACT |
| FD&C blue no. 2 | L06K8R7DQK | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| magnesium stearate | 70097M6I30 | IACT |
| microcrystalline cellulose | OP1R32D61U | IACT |
| propylene glycol | 6DC9Q167V3 | IACT |
| shellac | 46N107B71O | IACT |
| titanium dioxide | 15FIX9V2JP | IACT |
| triacetin | XHX3C3X673 | IACT |
Source Document#
openFDA label cross-check#
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 |
| 5797e7af-d592-4ed5-8727-147a232f3f7c | 1bf96671-9233-4b17-9d4c-d26982ca45be | 2022-04-18 | Warnings | 5797e7af-d592-4ed5-8727-147a232f3f7c 1bf96671-9233-4b17-9d4c-d26982ca45be |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.