Label: ACETAMINOPHEN CONGESTION AND PAIN- acetaminophen, phenylephrine hcl tablet, film coated

  • 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 August 22, 2018

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

  • Active ingredients (in each caplet)

    Acetaminophen 325 mg

    Phenylephrine HCl 5 mg

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  • Purpose

    Pain reliever/fever reducer

    Nasal decongestant

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  • Uses

    temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
    headache
    sinus congestion and pressure
    nasal congestion
    minor aches and pains
    helps decongest sinus openings and passages
    promotes sinus drainage
    helps clear nasal passages
    temporarily reduces fever
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  • Warnings

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

    more than 4,000 mg of acetaminophen in 24 hours
    with other drugs containing 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.

    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.
    if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if you have

    liver disease
    heart disease
    high blood pressure
    thyroid disease
    diabetes
    trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin

    When using this product

    do not exceed recommended dosage

    Stop use and ask a doctor if

    nervousness, dizziness, or sleeplessness occur
    pain or nasal congestion gets worse or lasts more than 7 days
    fever gets worse or lasts 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: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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  • Directions

    do not take more than directed (see overdose warning)

    adults and children 12 years and over

    take 2 caplets every 4 hours
    swallow whole – do not crush, chew or dissolve
    do not take more than 10 caplets in 24 hours

    children under 12 years

    ask a doctor

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  • Inactive ingredients

    acesulfame potassium, carnauba wax, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

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  • Questions or comments?

    1-800-616-2471

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  • Principal Display Panel

    Compare to the active ingredients in Tylenol® SINUS + HEADACHE

    Acetaminophen

    CONGESTION AND PAIN

    CAPLETS

    Acetaminophen – Pain reliever / Fever reducer

    Phenylephrine HCl – Nasal decongestant

    Relieves: Sinus Headache, Sinus Pressure & Nasal Congestion

    Actual Size

    For Adults

    24 CAPLETS

    with cool Blast Flavor

    NON-DROWSY

    DAYTIME

    272-5c-acetaminophen.jpg
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  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN CONGESTION AND PAIN 
    acetaminophen, phenylephrine hcl tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6760
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POVIDONES (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Color GREEN Score no score
    Shape OVAL Size 16mm
    Flavor VANILLA (menthol) Imprint Code L272
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-6760-24 12 in 1 CARTON 01/15/2007
    1 2 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 01/15/2007
    Labeler - Major Pharmaceuticals (191427277)
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