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Syncol

MarcasUSA LLC

SYNCOL


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Drug Facts

Active ingredients (in each caplet) Purpose

Purpose

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

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

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

Syncol 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

Syncol 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

Syncol
Carton

Syncol

Acetaminophen, Pamabrom, Pyrilamine Maleate CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:75940-131
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg
PAMABROM BROMOTHEOPHYLLINE 25 mg
PYRILAMINE MALEATE PYRILAMINE 15 mg

Inactive Ingredients

Ingredient Name Strength
MAGNESIUM STEARATE
cellulose, microcrystalline
SILICON DIOXIDE

Product Characteristics

Color Size Imprint Code Shape
WHITE 19 mm SYNCOL CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 24 in 1 BLISTER PACK
2 NDC:75940-131-24 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2012-03-15


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Be sure to consult your doctor before taking any medication!
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