SYNCOL- acetaminophen, pamabrom and 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:

  • cramps
  • headache
  • bloating
  • backache
  • water-weight gain
  • muscular aches
  • irritability

Warnings

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

  • liver disease
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland

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

Stop use and ask a doctor if

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

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 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

  • adults and children 12 years and over:
  • take 2 caplets with water every 6 hours as needed
  • do not exceed 8 caplets in a 24 hour period or as directed by a doctor
  • do not use more than directed (see warnings)
  • children under 12 years:
  • consult a doctor

Other information

store at 15° - 30°C (59° - 86°F) and in a dry place

Inactive ingredients

magnesium stearate, microcrystalline cellulose, silicon dioxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 24 Capsules

NDC 75940-131-24

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

See new warnings information - Acetaminophen

sanfer

Carton

Carton

SYNCOL 
acetaminophen, pamabrom, pyrilamine maleate capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75940-131
Route of AdministrationORALDEA Schedule    
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
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code SYNCOL
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75940-131-241 in 1 CARTON
124 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 FINALpart34303/15/201207/01/2013
Labeler - MarcasUSA LLC (016139820)

Revised: 7/2015
Document Id: 8ad5b5f9-0d61-4f66-8b86-0fdcd9b77401
Set id: 4f742f12-588f-464d-9fbf-ca699d100878
Version: 3
Effective Time: 20150702
 
MarcasUSA LLC