Label: GILPHEX TR- guaifenesin and phenylephrine hcl tablet, film coated

  • NDC Code(s): 58552-313-01, 58552-313-02
  • Packager: Gil Pharmaceutical Corp
  • 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 October 26, 2018

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

  • Drug Facts

    Active ingredient (in each tablet)

    Guaifenesin 388 mg

    Phenylephrine HCl 10 mg

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  • PURPOSE

    Purpose

    Expectorant

    Nasal Decongestant

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  • Uses

    temporarily relieves these symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies

    • helps loosen phlegm (mucus)
    • loosens nasal congestion
    • thin bronchial secretions
    • drain bronchial tubes
    • make coughs more productive
    • clears stuffy nose
    • clear nasal passageways
    • shrinks swollen membranes
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  • WARNINGS

    Do not use this product more than the recommended dosage, or 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 are uncertain whether your prescription drug contains an MAOI, ask a health professional.

    Ask a doctor before use if you have

    • heart disease
    • excessive phlegm (mucus)
    • high blood pressure
    • diabetes
    • thyroid disease
    • difficulty in urination due to enlargement of the prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occurs
    • symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus)
    • cough and congestion do not improve within 7 days or tend to recur.

    These could be signs of a serious condition.

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

    Keep out of the reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

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  • Directions

    Do not exceed recommended doses in a 24 hour period

    • Adults and Children 12 years and over: 1 tablet every 4 hours. Do not exceed 6 tablets in 24 hours.
    • Children 6 to 12 years: 1/2 tablet every 4 hours. Do not exceed 3 tablets in 24 hours
    • Children under 6 years of age: ask a doctor
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  • Other information

    • Store at room temperature, USP
    • do not use if imprinted safety seal under cap is broken or missing
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  • INACTIVE INGREDIENT

    Croscarmellose Sodium, Hypromellose, Lactose, Magnesium Silicate, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol, Polyvinylpyrrolidone, Silica, Sodium Lauryl Sulfate, Stearic Acid, Titanium Dioxide and Triacetin.

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  • Questions?

    Call 787-848-9114


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  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    GIL PHARMACEUTICAL CORP.,

    Ponce, Puerto Rico 00716


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  • PRINCIPAL DISPLAY PANEL

    NDC: 58552-313-01

    GILPHEX TOTAL RELEASE

    EXPECTORANT AND NASAL DECONGESTANT

    DYE FREE AND PRESERVATIVE FREE

    Each scored tablet contains:

    Guaifenesin 388 mg

    Phenylephrine HCl 10 mg

    100 Tablets

    MANUFACTURED FOR:

    GIL PHARMACEUTICAL CORP.

    PONCE, PUERTO RICO 00716

    4062-Gil-label

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  • INGREDIENTS AND APPEARANCE
    GILPHEX TR 
    guaifenesin and phenylephrine hcl tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:58552-313
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 388 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    TALC (UNII: 7SEV7J4R1U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    Color white Score 2 pieces
    Shape OVAL Size 19mm
    Flavor Imprint Code GIL;GIL;304;304
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58552-313-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/13/2011
    2 NDC:58552-313-02 12 in 1 CARTON 07/15/2011
    2 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 02/12/2008
    Labeler - Gil Pharmaceutical Corp (176826592)
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