Histiacil Cough

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

ACTIVE INGREDIENTS (in each softgel)	PURPOSE
Dextromethorphan HBr 20 mg	Cough suppressant
Guaifenesin 400 mg	Expectorant

Uses

INDICATIONS & USAGE SECTION

helps loosen phlegm (mucus)

helps thin bronchial secretions to make coughs more productive

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Overdose warning

SPL UNCLASSIFIED SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Avoid excessive heat and humidity

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Exclusively distributed by:
OPMX
Chula Vista, CA 91910

PRINCIPAL DISPLAY PANEL - 20 Softgel Blister Pack Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69729-000-00

Histiacil NF

Dextromethorphan HBr
Guaifenesin

Cough

Expectorant & Cough Supressant

• Controls cough
• Thins & loosens mucus
• Easy to swallow

20 Softgels Box

Product Linked Resources#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

• Histiacil Cough
• DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
• DEXTROMETHORPHAN HYDROBROMIDE
• DEXTROMETHORPHAN
• GUAIFENESIN
• D&C YELLOW NO. 10
• GELATIN, UNSPECIFIED
• GLYCERIN
• POLYETHYLENE GLYCOL, UNSPECIFIED
• POVIDONE, UNSPECIFIED
• PROPYLENE GLYCOL
• WATER
• TITANIUM DIOXIDE

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.