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  5. Label Information: Giltuss Hbp Ex Expectorant

FDA Label for Giltuss Hbp Ex Expectorant

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT PURPOSE (IN EACH EXTENDED-RELEASE BI-LAYER TABLET)
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. STOP USE AND ASK A DOCTOR IF
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENT
    12. QUESTIONS OR COMMENTS?
    13. PRINCIPAL DISPLAY PANEL

Giltuss Hbp Ex Expectorant Product Label

The following document was submitted to the FDA by the labeler of this product Gil Pharmaceutical Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts




Active Ingredient Purpose (In Each Extended-Release Bi-Layer Tablet)



Guaifenesin, 600 mg....................................................................Expectorant


Uses



  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and helps make cough more productive.

Warnings



  • Do not use for children under 12 years

Ask A Doctor Before Use If You Have



  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)

Stop Use And Ask A Doctor If



Cough lasts more than than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of serious illness.


Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of accidental overdose, get medical or professional help or contact a Poison Control Center right away (1-800-222-1222).


Directions



  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for the timing of meals
  • adults and children 12 years of age and over: 1 or 2 tablets every 12 hours
  • do not exceed 4 tablets in 24 hours
  • children under 12 years of age: do not use

Other Information



  • Tamper evident: do not use if the carton is open or if printed seal on bottle is broken or missing
  • Store between 20°-25°C (68°-77°F)
  • SAVE CARTON FOR COMPLETE DRUG FACTS

Inactive Ingredient



Inactive ingredients:carbomer homopolymer type B; hypromellose; magnesium stearate; microcrystalline cellulose, sodium starch  glycolate.


Questions Or Comments?



Call 1-787-848-9114, Monday–Friday 9AM-5PM EST. Call your doctor for medical advice in the event of side effects.

revised: 08/25


Principal Display Panel



GILTUSS HBP EX EXPECTORANT / EXPECTORANTE (Guaifenesin 600 mg) - NDC 58552-340-20 - 20 Tabs Bottle label

image description - glituss hbx expectorant tabs 600mg 20s bottle label

image description - glituss hbx expectorant tabs 600mg 20s bottle label


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