Indications and uses
for the temporary relief of these symptoms associated with menstrual periods: cramps headache bloating backache water-weight gain muscular aches irritability
for the temporary relief of these symptoms associated with menstrual periods: cramps headache bloating backache water-weight gain muscular aches irritability
do not take more than the recommended dose adults and children 12 years and over: take 2 caplets with water every 6 hours as needed do not exceed 6 caplets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Drug Facts
| Active ingredients (in each caplet) | Purpose |
Acetaminophen 500 mg ..........................................Pain reliever
Pamabrom 25 mg ....................................................Diuretic
Pyrilamine maleate15 mg........................................Antihistamine
for the temporary relief of these symptoms associated with menstrual periods:
Liver warning: This product contains acetaminophen. The maximum daily dose
of this product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage may
occur if you take:
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may
include:
If a skin 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.
These could be signs of a serious condition.
ask a health professional before use.
In case of overdose, get medical help or
contact a Poison Control Center (1-800-222-1222) right away.
corn starch, croscarmellose sodium,
crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose,
polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid,
titanium dioxide, triacetin
1-800-428-9489
| Ingredientes activos (en cada comprimido) | Propósito |
Acetaminofén 500 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Alivio del dolor
Pamabrom 25 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Diurético
Maleato de pirilamina 15 mg . . . . . . . . . . . . . . . . . . . . . . . . . . .Antihistamínico
Usos
para el alivio temporal de estos síntomas asociados con los períodos
menstruales:
Advertencias
Advertencia para el hígado: Este producto contiene acetaminofén. La dosis
diaria máxima de este producto es de 6 comprimidos (3,000 mg) en 24 horas.
Puede causar daño grave al hígado si toma
Alerta para alergias: Acetaminofén puede causar reacciones severas en la
piel. Los síntomas pueden incluir:
Si su piel tiene una reacción, deje de usar el medicamento inmediatamente y
busque ayuda médica.
No usar con ningún otro medicamento que contenga acetominofén (con o
sin receta). Si no está seguro si un medicamento contiene acetaminofén,
consulte a un médico o farmacéutico.
Consulte a un médico antes de usar si usted tiene
Pregunte a un médico o farmacéutico antes de usar si usted está
Al utilizar este producto
Suspenda el uso y consulte a un médico si
Estas pueden ser señales de una condición seria.
Si está embarazada o amamantando, consulte a un profesional de la salud
antes de usar.
Mantener fuera del alcance de los niños. En caso de sobredosis, obtenga
atención médica inmediatamente o llame a un Poison Control Center
(1-800-222-1222).
Modo de Empleo
Otra información
Ingredientes inactivos almidón de maíz, croscarmelosa de sodio,
crospovidona, hipromelosa, estearato de magnesio, celulosa microcristalina,
polidextrosa, polietilenglicol, povidona, dióxido de silicio, ácido esteárico,
dióxido de titanio, triacetín
Preguntas y comentarios
Llame Gratis al 1-800-428-9489
SYNCOL ®
Acetaminophen / Pamabrom / Pyrilamine Maleate
Pain Reliever / Diuretic / Antihistamine
Multi-Symptom Relief of
Premenstrual & Menstrual Pain
including Menstrual Cramps
Alivio Multi-síntomas de dolores
Premenstruales y Menstruales
incluyendo Cólicos Menstruales
24 Caplets / Comprimidos

| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1248906 | acetaminophen 500 MG / pamabrom 25 MG / pyrilamine maleate 15 MG Oral Capsule | PSN | 1 |
| 1248912 | SYNCOL Multi-Symptom Relief 500 MG / 25 MG / 15 MG Oral Capsule | PSN | 1 |
| 1248912 | acetaminophen 500 MG / pamabrom 25 MG / pyrilamine maleate 15 MG Oral Capsule [Syncol] | SBD | 1 |
| 1248906 | acetaminophen 500 MG / pamabrom 25 MG / pyrilamine maleate 15 MG Oral Capsule | SCD | 1 |
| 1248906 | APAP 500 MG / pamabrom 25 MG / Pyrilamine Maleate 15 MG Oral Capsule | SY | 1 |
| 1248912 | APAP 500 MG / pamabrom 25 MG / Pyrilamine Maleate 15 MG Oral Capsule [Syncol] | SY | 1 |
| 1248912 | Syncol (APAP 500 MG / pamabrom 25 MG / pyrilamine maleate 15 MG) Oral Capsule | SY | 1 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 75940-141-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-eed6-f424-e053-dadaa90a57ce | SYNCOL |
| 75940-141-24 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-eed6-f424-e053-dadaa90a57ce | SYNCOL |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 75940-141-02 | Syncol | 1 in 1 CARTON | CAPSULE | 1 | 1 | |
| 75940-141-02 | Syncol | 2 in 1 BLISTER PACK | CAPSULE | 2 | 1 | |
| 75940-141-24 | Syncol | 2 in 1 CARTON | CAPSULE | 2 | 1 | |
| 75940-141-24 | Syncol | 12 in 1 BLISTER PACK | CAPSULE | 12 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| PAMABROM | ACTIVE INGREDIENT | UA8U0KJM72 | 1 | |
| PYRILAMINE MALEATE | ACTIVE INGREDIENT | R35D29L3ZA | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| BROMOTHEOPHYLLINE | ACTIVE MOIETY | FZG87K1MQ6 | 1 | |
| PYRILAMINE | ACTIVE MOIETY | HPE317O9TL | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 75940-141 | 75940-141-24, 75940-141-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| PAMABROM | UA8U0KJM72 | ACTIB |
| PYRILAMINE MALEATE | R35D29L3ZA | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| CROSPOVIDONE | 68401960MK | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POLYDEXTROSE | VH2XOU12IE | IACT |
| POLYETHYLENE GLYCOLS | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| TRIACETIN | XHX3C3X673 | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA | ||
| POVIDONE | POVIDONE | FZ989GH94E | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 350 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, COATED / ORAL | 58 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / DENTAL | 19 %w/w | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IMPLANT / INTRAVITREAL | 1.66 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | SUSPENSION / ORAL | 150 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | DROPS / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / OPHTHALMIC | 0.5 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / SUBLINGUAL | 10 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TAMPON / VAGINAL | NA | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, CHEWABLE / ORAL | 11.8 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 11 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, LIQUID FILLED / ORAL | 12 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION / ORAL | 900 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, FOR SUSPENSION / ORAL | 1875 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CAPSULE, EXTENDED RELEASE / ORAL | 119.7 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, DELAYED RELEASE / ORAL | 53 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, EXTENDED RELEASE / ORAL | 184 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING / ORAL | 100 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE / DENTAL | 0.5 %w/w | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | DROPS / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION, EXTENDED RELEASE / ORAL | 1120 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | RING / VAGINAL | 2 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, DELAYED RELEASE / ORAL | 789.6 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SHAMPOO / TOPICAL | 9.7 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | LOTION / TOPICAL | NA | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TROCHE / ORAL | 50 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE / ORAL | 5785 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CONCENTRATE / ORAL | NA | ||
| POVIDONE | POVIDONE | FZ989GH94E | SUSPENSION / ORAL | 20 mg/5ml | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 2 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, COATED PELLETS / ORAL | 10.03 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 42 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | TABLET, COATED / ORAL | 1 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FOR SUSPENSION / ORAL | 20100 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | CREAM / TOPICAL | 0.1 %w/w | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION/ DROPS / ORAL | 90 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION / ORAL | 64 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | POWDER, FOR SUSPENSION / ORAL | 35 mg/5ml | ||
| POVIDONE | POVIDONE | FZ989GH94E | SYSTEM / TOPICAL | 41 mg | ||
| TRIACETIN | TRIACETIN | XHX3C3X673 | TABLET, EXTENDED RELEASE / ORAL | 26 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w |
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 |
|---|---|---|---|---|---|---|
| 91f6e47e-186e-454d-8d55-62edafb1b9bc | 39f4b936-612f-45f7-b4c3-c78c4e056e8b | 2015-07-09 | Warnings | 91f6e47e-186e-454d-8d55-62edafb1b9bc 39f4b936-612f-45f7-b4c3-c78c4e056e8b |
Adverse event summaries are temporarily unavailable. Other product information remains available.