Acetaminophen congestion and pain tablet, film coated

Active ingredients (in each caplet)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Nasal decongestant

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

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 Parkinsons 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.

Directions

  • do not take more than directed (see overdose warning)
take 2 caplets every 4 hours
  • swallow whole do not crush, chew or dissolve
  • do not take more than 10 caplets in 24 hours

    adults and children 12 years and over

    children under 12 years

    ask a doctor

    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

    Questions or comments?

    1-800-616-2471

    Ingredients and appearance - Product information

    Acetaminophen congestion and pain tablet, film coated- Acetaminophen, phenylephrine hcl

    Product information

    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 0904-6760
    Route of Administration Oral

    Active Ingredient/Active Moiety

    Ingredient Name Strength
    Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 325 mgin 1
    Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 5 mgin 1

    Inactive Ingredients

    Ingredient Name Code
    Acesulfame potassium ( UNII: 23OV73Q5G9)
    Carnauba wax ( UNII: R12CBM0EIZ)
    Crospovidone (15 mpa.s at 5%) ( UNII: 68401960MK)
    Microcrystalline cellulose ( UNII: OP1R32D61U)
    Polyethylene glycol ( UNII: 3WJQ0SDW1A)
    Polyvinyl alcohol ( UNII: 532B59J990)
    Povidone ( 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 Size 16 mm
    Shape OVAL Score 1
    Imprint Code L272 Flavor VANILLA (menthol)

    Marketing Information

    Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
    OTC monograph final part341 USA

    Labeler - Major Pharmaceuticals( 191427277)

    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