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

  • NDC Code(s): 69729-143-02, 69729-143-06, 69729-143-72
  • Packager: OPMX LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated February 20, 2024

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  • 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. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reactio occurs, stop use and seek medical help right away

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly

  • Do not use

    • with any other product containing acetaminophen (prescription or nonprescription).

    If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    • 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, ask a doctor or pharmacist before taking this product.
    • for more than 7 days for pain and 3 days for fever, unless directed by a doctor
  • Ask a doctor before use

    if you have

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to enlarged prostate gland
    • a cough that is accompanied by excessive phlegm (mucus)
    • a persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • Ask a doctor or pharmacist

    before use if you are

    • taking the blood thinning drug warfarin
  • Stop use and ask a doctor if

    • new symptoms occur
    • redness or swelling is present
    • pain or fever persists or gets worse
    • nervousness, dizziness, or sleeplessness occur
    • a persistent cough or symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. 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 accidental 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 exceed recommended dosage
    • adults and children 12 years of age and over:

    take 2 tablets every 6 - 8 hours; do not exceed 8 tablets in a 24-hour period

    • children under 12 years of age: consult a doctor
  • Other Information

    • store at room temperature 59° to 86°F (15° to 30°C)
    • Avoid excessive heat and humidity

    TAMPER EVIDENCE: Do not use if packet is open or torn.

  • Inactive Ingredients

    Corn starch, crospovidone, microcrystalline cellulose, povidone k30, silicon dioxide, stearic acid, talc, water

  • Questions & comments?

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

  • SPL UNCLASSIFIED SECTION

    NDC 69729-143-06

    COLDTAC Plus

    Tablets

    Acetaminophen 325 mg / Guaifenesin 200 mg

    Dextromethorphan HBr 15 mg / Phenylephrine HCl 5 mg

    Effective and quick relief from

    cough, cold & flu symptoms

    Pain reliever, fever reducer

    Nasal Decongestant

    Cough Suppressant

    Expectorant

    Contents 12 Tablets

    Exclusively distributed by OPMX

    San Diego, CA 92154

    Phone: 619-600-5632

  • PRINCIPAL DISPLAY PANEL

    carton label

    packet label

  • INGREDIENTS AND APPEARANCE
    COLDTAC PLUS 
    acetaminophen, phenylephrin hydrochloride, dextromethorphan hydrobromide tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-143
    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
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POVIDONE K30 (UNII: U725QWY32X)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    TALC (UNII: 7SEV7J4R1U)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeCAPSULESize16mm
    FlavorImprint Code A15
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69729-143-066 in 1 PACKAGE01/05/2018
    1NDC:69729-143-022 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:69729-143-7272 in 1 PACKAGE01/05/2018
    2NDC:69729-143-022 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 - OPMX LLC (029918743)