OTC - ACTIVE INGREDIENT SECTION
(in each caplet)
Acetaminophen 500 mg
Pamabrom 25 mg
Pyrilamine maleate 15 mg
(in each caplet)
Acetaminophen 500 mg
Pamabrom 25 mg
Pyrilamine maleate 15 mg
Pain reliever
Antihistamine
Diuretic
For the temporary relief of these symptoms associated with menstrual periods:
Allergy Warning: Acetaminophen may cause severe skin reactions.
Symptoms may include:
if a skin reaction occurs stop use and seek medical help right away.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
more than 8 caplets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
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.
Ask a doctor before use if you have:
Ask a doctor or pharmacist before use if you are:
stop use and ask doctor if:
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
you have
if you are
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.
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.
adults and children 12 years and over:
children under 12 years: ask a doctor
blue 2, candelilla wax, corn starch, ethylparaben, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregalatinized starch, propylaparaben, red 40, sodium starch glycolate, stearic acid, talc, titanium dioxide
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1052637 | acetaminophen 500 MG / pamabrom 25 MG / pyrilamine maleate 15 MG Oral Tablet | PSN | 8 |
| 1052641 | Premsyn PMS 500 MG / 25 MG / 15 MG Oral Tablet | PSN | 8 |
| 1052641 | acetaminophen 500 MG / pamabrom 25 MG / pyrilamine maleate 15 MG Oral Tablet [Premsyn PMS] | SBD | 8 |
| 1052637 | acetaminophen 500 MG / pamabrom 25 MG / pyrilamine maleate 15 MG Oral Tablet | SCD | 8 |
| 1052637 | APAP 500 MG / pamabrom 25 MG / pyrilamine maleate 15 MG Oral Tablet | SY | 8 |
| 1052641 | APAP 500 MG / pamabrom 25 MG / Pyrilamine Maleate 15 MG Oral Tablet [Premsyn PMS] | SY | 8 |
| 1052641 | Premsyn PMS (APAP 500 MG / pamabrom 25 MG / pyrilamine maleate 15 MG) Oral Tablet | SY | 8 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71687-3102-4 | 2025-04-14 | C162847 | 48780-1 | 2cef2736-8f8b-d83d-e063-dadaa90ab31f | Premsyn pms Premenstrual Pain Relief |
| 71687-3102-4 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8f8b-d83d-e063-dadaa90ab31f | Premsyn pms Premenstrual Pain Relief |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71687-3102-4 | Premsyn pms Premenstrual Pain Relief | 40 in 1 BOTTLE, PLASTIC | TABLET | 40 | 8 | |
| 71687-3102-4 | Premsyn pms Premenstrual Pain Relief | 1 in 1 CARTON | TABLET | 1 | 8 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71687-3102 | PREMSYN PMS PREMENSTRUAL PAIN RELIEF (ACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATE) TABLET [FOCUS CONSUMER HEALTHCARE, LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250416_5b6f6260-69ae-cfeb-e053-2a91aa0a6b49.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 71687-3102 | 71687-3102-4 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CROSPOVIDONE | 68401960MK | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POVIDONE | FZ989GH94E | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| PAMABROM | UA8U0KJM72 | 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 |
|---|---|---|---|---|---|---|
| Premsyn pms Premenstrual Pain Relief | ACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATE | Focus Consumer Healthcare, LLC | 5b6f6260-69ae-cfeb-e053-2a91aa0a6b49 | 2025-04-14 | Warnings | 71687-3102-4 71687-3102 71687310204 32bde825-4a2d-de16-e063-6394a90a7941 5b6f6260-69ae-cfeb-e053-2a91aa0a6b49 |
Adverse event summaries are temporarily unavailable. Other product information remains available.