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Drug Facts
Exclusively distributed by:
OPMX
Chula Vista, CA 91910
Histiacil Cough Capsule
FDA Label NDC 69729-108
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Histiacil Cough (NDC 69729-108). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| ACTIVE INGREDIENTS (in each softgel) | PURPOSE |
|---|---|
| Dextromethorphan HBr 20 mg | Cough suppressant |
| Guaifenesin 400 mg | Expectorant |
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
- Controls cough
- Thins & loosens mucus
- Easy to swallow
20 Softgels Box
Principal Display Panel (20 Softgel Blister Pack Box)
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