Label: PHENYLEPHRINE HYDROCHLORIDE- phenylephrine hydrochloride tablet, coated 

  • NDC Code(s): 57344-131-02, 57344-131-03, 57344-131-04, 57344-131-05
  • Packager: AAA Pharmaceutical, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

    Phenylephrine HCl 10 mg

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  • Purpose

    Nasal decongestant

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  • Uses

    • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, and nasal congestion associated with sinusitis
    • temporarily relieves sinus congestion and pressure
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  • Warnings

    Do not use 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

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

    When using this product

    • do not use more than directed

    Stop use and ask a doctor if

    • you get nervous, dizzy, or sleepless
    • symptoms do not improve within 7 days or are accompanied by fever

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    • adults and children 12 years of age and over: take 1 tablet every 4 hours; do not take more than 6 tablets in 24 hours
    • children under 12 years of age: ask a doctor
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  • Other information

    • store at 15°-25°C (59°-77°F) in a dry place
    • retain carton for complete product information
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  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, D&C red #27, FD&C red #40, FD&C yellow #6, hypromellose, lactose anhydrous, magnesium stearate, polyethylene glycol, stearic acid, titanium dioxide

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  • SPL UNCLASSIFIED SECTION

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

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  • PRINCIPAL DISPLAY PANEL - 36 Tablet Blister Pack Carton

    RESTORE u

    NDC 57344-131-03

    COMPARE TO THE ACTIVE
    INGREDIENT IN SUDAFED PE®
    NASAL DECONGESTANT

    MAXIMUM
    STRENGTH

    NON-DROWSY

    Nasal Decongestant PE

    Phenylephrine HCl

    Relieves: • Nasal & Sinus Congestion • Sinus Pressure

    36 TABLETS - 10 mg each

    Principal Display Panel - 36 Tablet Blister Pack Carton
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  • INGREDIENTS AND APPEARANCE
    PHENYLEPHRINE HYDROCHLORIDE 
    phenylephrine hydrochloride tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57344-131
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    D&C RED NO. 27  
    FD&C RED NO. 40  
    FD&C YELLOW NO. 6  
    HYPROMELLOSES  
    ANHYDROUS LACTOSE  
    MAGNESIUM STEARATE  
    POLYETHYLENE GLYCOLS  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color RED Score no score
    Shape ROUND Size 7mm
    Flavor Imprint Code A;131
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57344-131-02 1 in 1 CARTON
    1 18 in 1 BLISTER PACK
    2 NDC:57344-131-03 2 in 1 CARTON
    2 18 in 1 BLISTER PACK
    3 NDC:57344-131-04 4 in 1 CARTON
    3 18 in 1 BLISTER PACK
    4 NDC:57344-131-05 1 in 1 CARTON
    4 150 in 1 BOTTLE, PLASTIC
    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)
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