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
  • 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 November 10, 2020

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 finalpart34108/26/2019
    Labeler - OPMX LLC (029918743)