Label: GILTUSS- dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride syrup 

  • Label RSS
  • NDC Code(s): 58552-122-01, 58552-122-08
  • Packager: Gil Pharmaceutical Corp
  • 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 05/11

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

  • Active ingredients

    (in each 5 mL teaspoonful) 

     Dextromethorphan HBr, 28 mg

    Guaifenesin, 388 mg

    Phenylephrine HCl, 10 mg

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  • Purposes

    Antitussive

    Expectorant

    Nasal Decongestant

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  • Uses

    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
    • temporarily relieves nasal congestion due to a cold
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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, or difficulty in urination due to enlargement of the prostate unless directed by a doctor
    • a cough with too much phlegm (mucus)
    • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Ask a doctor or pharmacist before use if you are

    taking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs).

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

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  • Directions

    • do not exceed recommended dosage
    • take every 6-8 hours
    adults and children 12 years & over 5 mL (1 teaspoonful)
    children 6 to under 12 years of age 2.5 mL (1/2 teaspoon)
    children 2 to 6 years of age 1.25 mL (1/4 teaspoon)
    children under 2 years of age Consult a doctor
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  • Other information

    • Tamper evident: Do not use if safety seal is broken or missing
    • Store at controlled room temperature, between 15°-30°C (59°-86°F)
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  • Inactive ingredients

    Artificial grape and vanilla flavor, bitter mask, citric acid, grapeskin extract, menthol, monoammonium glycyrrhizinate, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose. Sodium citrate may be used to adjust pH.

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  • Questions or Comments?

    Call 1-877-746-9114, Mon.-Fri. 8:00 am thru 5:00 pm EST. Call your doctor for medical advice in the event of side effects.


    Rev. 324:01 6/10

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  • Package/Label Principal Display Panel

    Image of Container Label

    NDC 58552-122-08

    GILTUSS®

    NEW IMPROVED FORMULA

    ANTITUSSIVE

    EXPECTORANT AND

    NASAL DECONGESTANT

    SUGAR FREE

    ALCOHOL FREE

    Each 5 mL (one teaspoonful) contains:

    Dextromethorphan HBr............................28 mg

    Guaifenesin.............................................388 mg

    Phenylephrine HCl..................................10 mg

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  • INGREDIENTS AND APPEARANCE
    GILTUSS 
    dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrup
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:58552-122
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 28 mg  in 5 mL
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 388 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    POLYETHYLENE GLYCOL 1450  
    PROPYLENE GLYCOL  
    MENTHOL  
    SORBITOL  
    SUCRALOSE  
    ANHYDROUS CITRIC ACID  
    SODIUM BENZOATE  
    GLYCYRRHIZIN, AMMONIATED  
    ANHYDROUS TRISODIUM CITRATE  
    Product Characteristics
    Color PURPLE (clear, purple) Score     
    Shape Size
    Flavor GRAPE (artificial grape flavor and grapeskin extract powder) , VANILLA (artificial vanilla flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58552-122-08 237 mL in 1 BOTTLE
    2 NDC:58552-122-01 30 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 10/19/2009
    Labeler - Gil Pharmaceutical Corp (176826592)
    Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)
    Establishment
    Name Address ID/FEI Business Operations
    Hi-Tech Pharmacal Co., Inc. 101196749 MANUFACTURE
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