Label: ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL tablet

  • NDC Code(s): 69729-122-06, 69729-122-27, 69729-122-37, 69729-122-38
  • Packager: OPMX LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 3, 2024

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

  • Drug Facts

  • Active ingredients

    Purpose

    Active ingredients (in each caplet)Purpose
    Acetaminophen 500 mgPain reliever
    Chlorpheniramine Maleate 4 mgAntihistamine
    Phenylephrine HCl 10 mgNasal decongestant

  • Uses

    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,
    • 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
    • if you have ever had an allergic reaction to this product or any of its ingredients.
    • to make a child sleepy

    Ask a doctor before use if you have:

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • glaucoma
    • diabetes
    • trouble urinating due to enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis

    Ask a doctor ot pharmacist if you are:

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizers

    When using this product:

    • do not use more than directed
    • excitability may occur, especially in children
    • drowsiness may occur
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • avoid alcohol drinks
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if:

    • nervousness, dizziness, or sleeplessness occur
    • 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.

    Overdose warning

    Taking more than directed can cause serious health problems. 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.

  • Directions

    • 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

  • Other information

    • Store at room temperature between 20-25°C (68-77ºF)
    • Tamper evident: Do not use if pouch is torn, broken or shows any sing of tampering

  • Inactive ingredients

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

  • Questions or comments?

    Call: (619) 600-5632 (Mon-Fri 9am-5pm EST) or https://www.opmx.us

  • Coldtac Ultra

    NDC 69729-122-06

    Coldtac Ultra 6C

    NDC 69729-122-37

    Coldtac Ultra 12C

    NDC 69729-122-38

    Coldtac Ultra 144C

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL 
    acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-122
    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:69729-122-272 in 1 POUCH; Type 0: Not a Combination Product08/26/201910/24/2022
    2NDC:69729-122-3712 in 1 POUCH; Type 0: Not a Combination Product08/26/2019
    3NDC:69729-122-38144 in 1 POUCH; Type 0: Not a Combination Product08/26/2019
    4NDC:69729-122-063 in 1 CARTON09/04/2023
    42 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/26/2019
    Labeler - OPMX LLC (029918743)