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DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN

Histiacil NF Children Pentrexcilina NF Children Brosolvan Children

Approved
Approval ID

8bb85b23-e9f6-48c7-84b0-15e0e26df4c5

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 15, 2025

Manufacturers
FDA

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

NDC Product Code69729-069
Application NumberM012
Marketing CategoryC200263
Route of AdministrationORAL
Effective DateMay 15, 2025
Generic NameDEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN

INGREDIENTS (11)

DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 10 mg in 5 mL
Code: 9D2RTI9KYH
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
GUAIFENESINActive
Quantity: 100 mg in 5 mL
Code: 495W7451VQ
Classification: ACTIB

DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN

PRODUCT DETAILS

NDC Product Code69729-036
Application NumberM012
Marketing CategoryC200263
Route of AdministrationORAL
Effective DateMay 15, 2025
Generic NameDEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN

INGREDIENTS (11)

ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 10 mg in 5 mL
Code: 9D2RTI9KYH
Classification: ACTIB
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
GUAIFENESINActive
Quantity: 100 mg in 5 mL
Code: 495W7451VQ
Classification: ACTIB

DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN

PRODUCT DETAILS

NDC Product Code69729-035
Application NumberM012
Marketing CategoryC200263
Route of AdministrationORAL
Effective DateMay 15, 2025
Generic NameDEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN

INGREDIENTS (11)

SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 10 mg in 5 mL
Code: 9D2RTI9KYH
Classification: ACTIB
GUAIFENESINActive
Quantity: 100 mg in 5 mL
Code: 495W7451VQ
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 3/18/2025

PRINCIPAL DISPLAY PANEL HISTIACIL

![HISTIACIL](/dailymed/image.cfm?name=-Histiacil+Children+EN- ES+%28RTE%29+Rev+11.2024+%28AKRON%29_001.jpg&id=875356)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/6/2022

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

LOINC: 42229-5Updated: 5/11/2022

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 5/6/2022

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/6/2022

Inactive ingredients

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/11/2022

Active Ingredient (in each 5 mL) Purpose

Dextromethorphan HBr USP 10 mg............. Cough suppressant

Guaifenesin, USP 100 mg............................... Expectorant

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/6/2022

Relieves:
• Chest congestion / Mucus
• Cough

WARNINGS SECTION

LOINC: 34071-1Updated: 5/6/2022

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

LOINC: 50566-9Updated: 5/6/2022

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

LOINC: 50565-1Updated: 5/6/2022

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

LOINC: 34068-7Updated: 5/11/2022

Directions

  • take evey 4 hours
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product

Age

Dose

Adults and children 12 years and over

2 teaspoonful (10 mL)

Children 6 to under 12 years

1 teaspoonful (5 mL)

Children under 6 years

Ask a doctor

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