Histiacil Nf

Histiacil Nf
SPL v7
SPL
SPL Set ID 826c2f47-00a6-4060-a7ad-1ef26ccfddd1
Route
ORAL
Published
Effective Date 2025-03-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (300 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Menthol Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Saccharin Sodium Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-01

Description

Dextromethorphan HBr USP 20 mg............. Cough suppressant Guaifenesin, USP 300 mg............................... Expectorant

Purpose

Dextromethorphan HBr USP 20 mg............. Cough suppressant Guaifenesin, USP 300 mg............................... Expectorant


Medication Information

Purpose

Dextromethorphan HBr USP 20 mg............. Cough suppressant Guaifenesin, USP 300 mg............................... Expectorant

Description

Dextromethorphan HBr USP 20 mg............. Cough suppressant Guaifenesin, USP 300 mg............................... Expectorant

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
Section 42229-5

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

Section 50565-1

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.

Section 50566-9

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.

Section 50570-1
  • 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.
Section 55105-1

Relieves:

• Chest congestion / Mucus

• Cough

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

Other Information
  • Store at 20°-25°C (68° -77°F). 
  • Do not refrigerate.
  • Retain carton for future reference on full labeling
Inactive Ingredients

citric acid, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol.

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
Principal Display Panel Brosolvan Adult

Principal Display Panel Histiacil Adult

Principal Display Panel Pentrexcilina Adult

Active Ingredient (in Each 5 Ml)                      purpose

Dextromethorphan HBr USP 20 mg............. Cough suppressant

Guaifenesin, USP 300 mg............................... Expectorant


Structured Label Content

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
Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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.

Section 50570-1 (50570-1)
  • 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.
Section 55105-1 (55105-1)

Relieves:

• Chest congestion / Mucus

• Cough

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

Other Information (Other information)
  • Store at 20°-25°C (68° -77°F). 
  • Do not refrigerate.
  • Retain carton for future reference on full labeling
Inactive Ingredients (Inactive ingredients)

citric acid, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol.

Ask A Doctor Before Use If You Have (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
Principal Display Panel Brosolvan Adult (PRINCIPAL DISPLAY PANEL BROSOLVAN ADULT)

Principal Display Panel Histiacil Adult (PRINCIPAL DISPLAY PANEL HISTIACIL ADULT)

Principal Display Panel Pentrexcilina Adult (PRINCIPAL DISPLAY PANEL PENTREXCILINA ADULT)

Active Ingredient (in Each 5 Ml)                      purpose (Active Ingredient (in each 5 mL)                      Purpose)

Dextromethorphan HBr USP 20 mg............. Cough suppressant

Guaifenesin, USP 300 mg............................... Expectorant


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)