NDC 75940-141 Syncol

NDC Product Code 75940-141

NDC CODE: 75940-141

Proprietary Name: Syncol What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: CAPSULE (C48336)
Size(s):
19 MM
Imprint(s):
SYNCOL
Score: 1

NDC Code Structure

NDC 75940-141-02

Package Description: 1 BLISTER PACK in 1 CARTON > 2 CAPSULE in 1 BLISTER PACK

NDC 75940-141-24

Package Description: 2 BLISTER PACK in 1 CARTON > 12 CAPSULE in 1 BLISTER PACK

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Syncol with NDC 75940-141 is a product labeled by Marcasusa Llc. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1248906 and 1248912.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • STARCH, CORN (UNII: O8232NY3SJ)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • CROSPOVIDONE (UNII: 68401960MK)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYDEXTROSE (UNII: VH2XOU12IE)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIACETIN (UNII: XHX3C3X673)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Marcasusa Llc
Labeler Code: 75940
Start Marketing Date: 07-01-2015 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Syncol Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Drug FactsActive ingredients (in each caplet) Purpose

Otc - Purpose

Acetaminophen 500 mg ..........................................Pain relieverPamabrom 25 mg ....................................................DiureticPyrilamine maleate15 mg........................................Antihistamine

Uses

  • For the temporary relief of these symptoms associated with menstrual periods:crampsheadachebloatingbackachewater-weight gainmuscular achesirritability

Warnings

  • Liver warning: This product contains acetaminophen. The maximum daily doseof this product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage mayoccur if you take:more than 4,000 mg of acetaminophen in 24 hourswith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms mayinclude:rashskin reddeningblistersIf a skin 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.

Ask A Doctor Before Use If You Have

  • Liver diseaseglaucomadifficulty in urination due to enlargement of the prostate glanda breathing problem such as emphysema or chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking the blood thinning drug warfarintaking sedatives or tranquilizers

When Using This Product

  • Avoid alcoholic beveragesdrowsiness may occurexcitability may occur, especially in childrenalcohol, sedatives and tranquilizers may increase drowsinessuse caution when driving or operating machinery

Stop Use And Ask A Doctor If

  • Redness or swelling is presentpain gets worse or lasts more than 10 daysfever gets worse or lasts more than 3 daysnew symptoms occurThese could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help orcontact a Poison Control Center (1-800-222-1222) right away.

Directions

  • Do not take more than the recommended doseadults and children 12 years and over:take 2 caplets with water every 6 hours as neededdo not exceed 6 caplets in 24 hours, unless directed by a doctorchildren under 12 years: ask a doctor

Other Information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKENstore at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)see end flap for expiration date and lot number

Inactive Ingredients

Corn starch, croscarmellose sodium,crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose,polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid,titanium dioxide, triacetin

Datos Del Medicamento

  • Ingredientes activos (en cada comprimido)PropósitoAcetaminofén 500 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Alivio del dolorPamabrom 25 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DiuréticoMaleato de pirilamina 15 mg . . . . . . . . . . . . . . . . . . . . . . . . . . .AntihistamínicoUsospara el alivio temporal de estos síntomas asociados con los períodosmenstruales:calambresdolores de cabezairritabilidadaumento de peso por la retención de aguahinchazóndolores de espaldadolores muscularesAdvertenciasAdvertencia para el hígado: Este producto contiene acetaminofén. La dosisdiaria máxima de este producto es de 6 comprimidos (3,000 mg) en 24 horas.Puede causar daño grave al hígado si tomamás de 4,000 mg de acetaminofén en 24 horasotros medicamentos que contengan acetaminofén3 o más bebidas alcohólicas cada día durante el uso de este producto.Alerta para alergias: Acetaminofén puede causar reacciones severas en lapiel. Los síntomas pueden incluir:enrojecimiento de la pielampollassarpullidosSi su piel tiene una reacción, deje de usar el medicamento inmediatamente ybusque ayuda médica.No usar con ningún otro medicamento que contenga acetominofén (con osin 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 tiene­una enfermedad hepáticaglaucomadificultad para orinar debido al agrandamiento de la glándula de la próstataun problema respiratorio como enfisema o bronquitis crónicaPregunte a un médico o farmacéutico antes de usar si usted estátomando el anticoagulante warfarinatomando sedantes o tranquilizantesAl utilizar este productopuede haber somnolenciaevite las bebidas alcohólicas puede haber excitabilidad, especialmente en los niños alcohol, sedantes y tranquilizantes pueden aumentar la somnolenciatenga cuidado al conducir un automóvil u operar maquinariaSuspenda el uso y consulte a un médico siel dolor empeora o dura más de 10 díasla fiebre empeora o dura más de 3 díasse presentan síntomas nuevosse presenta enrojecimiento o hinchazónEstas pueden ser señales de una condición seria.Si está embarazada o amamantando, consulte a un profesional de la saludantes de usar.Mantener fuera del alcance de los niños. En caso de sobredosis, obtengaatención médica inmediatamente o llame a un Poison Control Center(1-800-222-1222).Modo de Empleono tome más de la dosis recomendadaadultos y niños de 12 años y más:tome 2 comprimidos con agua cada 6 horas según sea necesariono exceda más de 6 comprimidos en un período de 24 horas, a menos que así lo indique un mediconiños menores de 12 años: consulte a un médicoOtra informaciónALTERACIóN EVIDENTE: NO USAR SI ELPAQUETE EXTERIOR ESTá ABIERTO O SI EL BLíSTER HA SIDO ROTO ORASGADOalmacenar a 25° (77°F ); variaciones permitidas entre 15° - 30° C (59° - 86°F)vea el ala externa de la caja para la fecha de caducidad y número de loteIngredientes 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, triacetínPreguntas y comentariosLlame Gratis al 1-800-428-9489

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