SYNCOL MAX- acetaminophen, caffeine, pyrilamine maleate tablet, film coated 
Laboratorios Sanfer, S.A. de C.V.

----------

Syncol 44-390

Active ingredients (in each caplet)

Acetaminophen 500 mg
Caffeine 60 mg
Pyrilamine maleate 15 mg

Purpose

Pain reliever
Diuretic
Antihistamine

Uses

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

Warnings

Liver warning: This product contains acetaminophen. 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • difficulty in urination due to enlargement of the prostate gland
  • liver disease
  • glaucoma
  • 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

  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • use caution when driving a motor vehicle or operating machinery
  • limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart rate. The recommended dose of this product contains about as much caffeine as a cup of coffee.

Stop use and ask a doctor if

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

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 right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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?

Call 1-(833)-604-1084 (English and Spanish) 8:00 AM-5:00 PM CST, Monday-Friday

Principal Display Panel

SYNCOL MAX®

Acetaminophen/Caffeine/Pyrilamine Maleate
Pain reliever/Diuretic/Antihistamine

Relieves Menstrual Cramps

√Fatigue     √Bloating

√Headache  √Backache

Actual Size
12 Caplets
sanfer®                                    

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF
BLISTER UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING

Manufactured for: Laboratorios Sanfer
S.A. de C.V. Blvd. Adolfo López Mateos
No. 314, Col. Tlacopac, CDMX, 01049. Mexico
This product is produced in compliance
with all United States regulatory and quality
requirements for pharmaceutical product.
50844 ORG062339002

Syncol 44-390

Syncol 44-390

SYNCOL MAX 
acetaminophen, caffeine, pyrilamine maleate tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83393-390
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE60 mg
PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE15 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize17mm
FlavorImprint Code 44;390
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83393-390-0224 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/09/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01302/09/2024
Labeler - Laboratorios Sanfer, S.A. de C.V. (810007732)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(83393-390)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(83393-390) , pack(83393-390)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(83393-390)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(83393-390)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(83393-390)

Revised: 4/2024
Document Id: cd46a724-7d3a-4715-8097-36d4ea52a480
Set id: c844d5c4-3e4b-4169-904e-eb5c3334bc4e
Version: 2
Effective Time: 20240409
 
Laboratorios Sanfer, S.A. de C.V.