Label: SYNCOL MAX- acetaminophen, caffeine, pyrilamine maleate tablet, film coated

  • NDC Code(s): 83393-390-02
  • Packager: Laboratorios Sanfer, S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 9, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • 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:

    • bloating
    • headache
    • water-weight gain
    • cramps
    • backache
    • fatigue
    • muscle aches 
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    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

    • do not take more than directed
    • adults and children 12 years and over:
      • take 2 caplets with water
      • repeat every 6 hours, as needed
      • do not exceed 6 caplets per day
    • children under 12 years: ask a doctor
  • Other information

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

  • INGREDIENTS AND APPEARANCE
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!