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  5. Label Information: Histiacil Cough

FDA Label for Histiacil Cough

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. DO NOT USE
    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. OVERDOSE WARNING
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL - 20 SOFTGEL BLISTER PACK BOX

Histiacil Cough Product Label

The following document was submitted to the FDA by the labeler of this product Opmx Llc. 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.

Other



Drug Facts

Exclusively distributed by:
OPMX
Chula Vista, CA 91910


Otc - Purpose



ACTIVE INGREDIENTS (in each softgel)PURPOSE
Dextromethorphan HBr 20 mgCough suppressant
Guaifenesin 400 mgExpectorant

Uses



helps loosen phlegm (mucus)

helps thin bronchial secretions to make coughs more productive


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



cough that occurs with too much phlegm (mucus)

cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema


Stop Use And Ask A Doctor If



cough lasts for more than 7 days, recurs, or is accompained by fever, rash, or persistent headache. These could be signs of a serious condition


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


Overdose Warning



In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Directions



Do not take more than directed - See Overdose warning

Do not use for more than 7 days.

Do not take more than 6 doses in 24 hours

Adults and children
12 years of age & over		Take 1 softgel every 4 hours with a full glass of water while symptoms persist
Children
under 12 years of age		Do not use

Other Information



Store at room temperature between 20-25°C (68-77°F)

Avoid excessive heat and humidity


Inactive Ingredients



FD&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.


Questions Or Comments?



Call: (619) 600-5632 (Mon-Fri 9am-5pm EST)


Principal Display Panel - 20 Softgel Blister Pack Box



NDC 69729-000-00

Histiacil NF

Dextromethorphan HBr
Guaifenesin

Cough

Expectorant & Cough Supressant

* Please review the disclaimer below.