Home > Drugs A-Z > Acetaminophen, Phenylephrine Hydrochloride

Acetaminophen, Phenylephrine Hydrochloride (AAA Pharmaceutical, Inc.)

Available Formats

Dosage Form Package Information Links
TABLET, COATED 2 BLISTER PACK in 1 CARTON (57344-120-06) > 12 TABLET, COATED in 1 BLISTER PACK Label Information
TABLET, COATED 2 BLISTER PACK in 1 CARTON (57344-120-02) > 12 TABLET, COATED in 1 BLISTER PACK Label Information
TABLET, COATED 4 BLISTER PACK in 1 CARTON (57344-120-03) > 12 TABLET, COATED in 1 BLISTER PACK Label Information

Complete Acetaminophen, Phenylephrine Hydrochloride Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • ACTIVE INGREDIENT

    Active ingredients (in each caplet) Purpose
    Acetaminophen 325 mg Pain reliever/fever reducer
    Phenylephrine HCl 5 mg Nasal decongestant

  • Uses

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

  • Warnings

    Liver warning

    This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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

    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.


  • Directions

    adults and children 12 years and over
    • take 2 caplets every 4 hours
    • do not take more than 10 caplets in 24 hours
    children under 12 years
    • ask a doctor

  • Other information

    • store between 20-25ºC (68-77ºF) in a dry place
    • retain carton for complete product information

  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, FD&C yellow #6, hypromellose, lactose, magnesium stearate, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate, stearic acid, titanium dioxide, triacetin


  • SPL UNCLASSIFIED SECTION

    Distributed by:
    AAA Pharmaceutical, Inc.
    681 Main Street
    Lumberton, NJ 08048


  • PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton

    RESTORE u

    NDC 57344-120-06

    †COMPARE TO THE ACTIVE
    INGREDIENTS IN SUDAFED PE®
    PRESSURE + PAIN

    MAXIMUM
    STRENGTH

    NON-DROWSY

    Pressure & Pain PE
    For Adults

    Acetaminophen, Phenylephrine HCl
    Pain Reliever/Fever Reducer, Nasal Decongestant

    Relieves: Sinus Headache Sinus Pressure
    Sinus Congestion

    FORMERLY
    SINUS HEADACHE PE

    24 CAPLETS

    PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE 
    acetaminophen and phenylephrine hydrochloride tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57344-120
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONES (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Color ORANGE Score no score
    Shape OVAL Size 17mm
    Flavor Imprint Code AAA;1114
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57344-120-02 2 in 1 CARTON
    1 12 in 1 BLISTER PACK
    2 NDC:57344-120-03 4 in 1 CARTON
    2 12 in 1 BLISTER PACK
    3 NDC:57344-120-06 2 in 1 CARTON
    3 12 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 12/22/2012
    Labeler - AAA Pharmaceutical, Inc. (181192162)