SYNCOL- acetaminophen, pamabrom, pyrilamine maleate capsule 
MarcasUSA LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SYNCOL

Drug Facts

Active ingredients (in each caplet) Purpose

Acetaminophen 500 mg ..........................................Pain reliever

Pamabrom 25 mg ....................................................Diuretic

Pyrilamine maleate15 mg........................................Antihistamine

Uses

for the temporary relief of these symptoms associated with menstrual periods:

Warnings

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.

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 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

  • avoid alcoholic beverages
  • drowsiness may occur
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • use caution when driving or operating machinery

Stop use and ask a doctor if

  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur

These 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 or
contact a Poison Control Center (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients

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

Questions or comments?

1-800-428-9489

Datos del Medicamento

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

PACKAGE LABEL PRINCIPAL DISPLAY PANEL - 24 Capsules

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

image description

image description
SYNCOL 
acetaminophen, pamabrom, pyrilamine maleate capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75940-141
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
PAMABROM (UNII: UA8U0KJM72) (BROMOTHEOPHYLLINE - UNII:FZG87K1MQ6) PAMABROM25  mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE15  mg
Inactive Ingredients
Ingredient NameStrength
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 Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code SYNCOL
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75940-141-242 in 1 CARTON
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:75940-141-021 in 1 CARTON
22 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34307/01/2015
Labeler - MarcasUSA LLC (016139820)

Revised: 7/2015
Document Id: 91f6e47e-186e-454d-8d55-62edafb1b9bc
Set id: 39f4b936-612f-45f7-b4c3-c78c4e056e8b
Version: 1
Effective Time: 20150709
 
MarcasUSA LLC