Label: COLDTAC PLUS- acetaminophen, phenylephrin hydrochloride, dextromethorphan hydrobromide tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated October 2, 2017

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.

  • 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 

  • WHEN USING

  • 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)

  • COLDTAC Plus2 Tablets in a pouch

    image description

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  • INGREDIENTS AND APPEARANCE
    COLDTAC PLUS 
    acetaminophen, phenylephrin hydrochloride, dextromethorphan hydrobromide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-143
    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:69517-143-063 in 1 PACKAGE10/02/2017
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:69517-143-7236 in 1 PACKAGE10/02/2017
    22 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/02/2017
    Labeler - Healthlife of USA (079656178)
    Establishment
    NameAddressID/FEIBusiness Operations
    Centurion Laboratories Pvt Ltd873229784manufacture(69517-143) , analysis(69517-143) , pack(69517-143)