DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
Histiacil NF Pentrexicilina NF Brosolvan
826c2f47-00a6-4060-a7ad-1ef26ccfddd1
HUMAN OTC DRUG LABEL
May 15, 2025
OPMX LLC
DUNS: 029918743
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (11)
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (11)
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (11)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL HISTIACIL ADULT
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
- helps to loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
SPL UNCLASSIFIED SECTION
Questions or comments?
** Call 619-600-5632**
Tamper evident: Do not use if inner seal under cap is broken or missing.
Exclusively distributed by
OPMX
Chula Vista, CA91910
Phone: 619-600-5632
Manufactured in
FDA Registered Facility
In the USA
INACTIVE INGREDIENT SECTION
Inactive ingredients
citric acid, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol.
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient (in each 5 mL) Purpose
Dextromethorphan HBr USP 20 mg............. Cough suppressant
Guaifenesin, USP 300 mg............................... Expectorant
OTC - PURPOSE SECTION
Relieves:
• Chest congestion / Mucus
• Cough
WARNINGS SECTION
Warnings
*Do not useif 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
OTC - STOP USE SECTION
Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
If pregnant or breast-feedingask a health professional before use.
**Keep out of reach of children.**In case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- ml=milliliter
- this adult product is not intended for use in children under 12 years of age
|
Age |
Dose |
|
Adults and children 12 years and over |
5 mL every 4 hours |
|
Children under 12 years |
do not use |
STORAGE AND HANDLING SECTION
Other information
- Store at 20°-25°C (68° -77°F).
- Do not refrigerate.
- Retain carton for future reference on full labeling