Label: ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL tablet

  • NDC Code(s): 69729-322-27, 69729-322-37, 69729-322-38
  • Packager: OPMX LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 11, 2022

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

  • ACTIVE INGREDIENT

    Acetaminophen 500mg

    Chlorpheniramine Maleate 4mg

    Phenylephrine HCl 10mg

  • PURPOSE

    Pain reliever/fever reducer

    Antihistamine

    Nasal decongestant

  • INACTIVE INGREDIENT

    magnesium stearate, povidone, silicon dioxide, sodium benzoate, sodium starch glycolate, starch, talc

  • DOSAGE & ADMINISTRATION

    • Do not take more than directed - see overdose warning
    • swallow whole; do not crush, chew or dissolve
    • do not exceed 6 tablets per 24 hours
    Adults and children 12 years of age & over1 tablet with water every 4-6 hours as needed
    Children 4 to 12 years of ageAsk a doctor
    Children under 4 years of ageDo not use

  • INDICATIONS & USAGE

    Temporarily relieves these symptoms of hay fever or other respiratory allergies:

    • Headache
    • Nasal congestion
    • Sinus congestion & pressure
    • Runny nose and sneezing
    • Minor aches & pain

    Temporarily relieves these additional symptoms of hay fever:

    • itching of the nose or throat
    • itchy, watery eyes
    • helps clear nasal passages
    • helps decongest sinus opening and passages
  • WARNINGS

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

    • more than 6 tablets in 24 hours, which is the maximum daily amount for this product
    • with other drugs contains 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.

    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 doctor promptly

    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 are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have:

    • Liver disease
    • High blood pressure
    • Thyroid disease
    • Diabetes
    • Trouble urinating due to enlarged prostate gland
    • 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.

    When using this product, do not use more than directed.

    Stop use and ask a doctor if:

    You get nervous, dizzy, or sleepless
    Pain, nasal congestion, or cough gets worse or lasts more than 7 days
    Fever gets worse or last more than 3 days
    Redness or swelling is present
    New symptoms occur

    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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    OVERDOSE WARNING: Read directions carefully. 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.

  • OTHER SAFETY INFORMATION

    store at room temperature between 20-25°C (68-77ºF)

    avoid excessive heat and humidity

  • PRINCIPAL DISPLAY PANEL

    382737

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL 
    acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-322
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUND (BICONVEX) Size13mm
    FlavorImprint Code S78
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69729-322-272 in 1 POUCH; Type 0: Not a Combination Product08/26/2019
    2NDC:69729-322-3712 in 1 POUCH; Type 0: Not a Combination Product08/26/2019
    3NDC:69729-322-38144 in 1 POUCH; Type 0: Not a Combination Product08/26/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/26/2019
    Labeler - OPMX LLC (029918743)