Label: PENTREXCILINA- acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet

  • NDC Code(s): 69517-155-06, 69517-155-72
  • Packager: Healthlife of USA
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 21, 2023

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

  • Drug Facts

    Active Ingredients (in each tablet)

    Acetaminophen USP 325mg.........................................................Pain reliever/fever reducer

    Guaifenesin USP 200mg..............................................................Expectorant

    Phenylephrine HCL USP 5mg........................................................Decongestant

    Dextromethorphan HBr USP 15mg................................................Antitussive

  • Purpose

    Pain reliever/ fever reducer

    Expectorant

    Decongestant

    Antitussive

  • Uses

    Temporarily

    • Relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    • Relieves sinus congestion and pressure, helps decongest sinus openings and passages
    • Restores freer breathing
    • Helps loosen bothersome mucus, drain bronchial tubes, and make coughs more productive
    • Suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants
    • Temporarily relieves minor aches, pains and fever associated with: headache, common cold, toothache, backache, muscular aches, menstrual cramps
  • Warnings: Liver Warning:

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

    • More than 8 tablets in 24 hours
    • With other drugs containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure
    • 3 or more alcoholic drinks every day while using this product
  • Allergy alert:

    Acetaminophen may cause severe skin reactions. Symproms may include: skin reddening, blisters, rash if a skin reaction occurs, stop use and seek medical help right away.

    Warning: A persistent cough may be a sign of a serious condition

  • Do not

    • use with any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and cold cause serious health concerns.
    • use more than the recommended dose
    • for more than 10 days for pain unless directed by a doctor
    • for more than 3 days for fever unless directed by a doctor
    • when using this product do not exceed recommended dose
    • if you are now taking a presription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product
    • take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
  • Stop use and ask a doctor if:

    symptoms do not improve, pain or fever persists or gets worse, new symptoms occur, redness or swelling is present, symptoms do not improve within 7 days or are accompanied by fever, cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition

  • Ask a doctor before use if you have:

    heart disease, high blood pressure, thyroid disease, diabetes, difficulty in urination due to enlargement of the prostate gland, liver disease

  • Ask a doctor or pharmacist if you are

    taking the blood thinning drug warfarin.

  • Do not exceed recommended dosage

    if nervousness, dizziness, or sleeplessness occur, discontinue use consult a doctor.

  • 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 nnotice any signs or symptoms

  • Directions:

    Adults and children 12 years of age and older: Take 2 tablets every 6 to 8 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor. Children under 12 years, consult a doctor

  • Other Inforamtion:

    • Tamper evident. Do not use if packet is torn, cut or opened
    • Store at controlled room temperature 15° to 30°C (59° to 86°F)
    • Avoid excessive heat and humidity
  • Inactive Ingredients

    maltodextrin, microcrystalline cellulose, povidone, silicon dioxide*, sodium starch glycolate, starch, stearic acid

    (*may contain)

  • Questions or comments?

    Call: 619-600-5632 (Mon-Fri 9am - 5pm EST)

  • Pentrexcilina 2 Tablets in a pouch

    pentrexcilina-2

    pentrexcilina-12-eng

    pentrexcilina-72

  • INGREDIENTS AND APPEARANCE
    PENTREXCILINA 
    acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-155
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeCAPSULESize16mm
    FlavorImprint Code A15
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69517-155-066 in 1 PACKAGE01/05/2018
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:69517-155-7272 in 1 PACKAGE01/05/2018
    22 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/05/2018
    Labeler - Healthlife of USA (079656178)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vovantis Laboratories Private Limited650502151manufacture(69517-155)