DEXTROMETHORPHAN HBR AND GUAIFENESIN ORAL SOLUTION liquid

Dextromethorphan HBr and Guaifenesin Oral Solution by

Drug Labeling and Warnings

Dextromethorphan HBr and Guaifenesin Oral Solution by is a Otc medication manufactured, distributed, or labeled by KESIN PHARMA CORPORATION, Kesin Pharma Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Dextromethorphan HBr and Guaifenesin Oral Solution 5 and 10 mL

Disclaimer: Most OTC drugs are not reviewed and approved by the FDA, however, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DM Guaifenesin
Non-Narcotic, Sugar, Dye and Alcohol Free
Cough Suppressant/Expectorant

DESCRIPTION

Each 5 mL (1 teaspoonful) contains:

Dextromethorphan Hydrobromide 10 mg

Guaifenesin 100 mg

Each 10 mL (2 teaspoonfuls) contains:

Dextromethorphan Hydrobromide 20 mg

Guaifenesin 200 mg

Inactive Ingredients

Inactive Ingredients: citric acid, glycerin, mixed berry flavor, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol, sucralose, trisodium citrate, xanthan gum
Sodium Content: 4 mg/5 mL

USES

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

WARNINGS

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

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 more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
• you are hypersensitive to any of the ingredients.

If pregnant or breast-feeding

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

Keep out of reach of children.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA)

DIRECTIONS

DIRECTIONS

Follow dosage table below or use as directed by a
physician

• Do not take more than 6 doses in any 24-hour period

• Age: Dose
• adults and children 12 years and over: 10mL (2 teaspoonful) every 4 hours
• children 6 to under 12 years of age: 5mL (1 teaspoonful) every 4 hours
• children 2 to under 6 years of age: 2.5mL (1/2 teaspoonful) every 4 hours
• children under 2 years: consult a doctor

HOW SUPPLIED

Dextromethorphan hydrobromide and Guaifenesin is a clear, mixed berry flavor solution supplied in the following oral dosage forms:
5 mL unit dose cup:
NDC: 81033-103-05
Case containing 100 units dose cups of 5 mL:
NDC: 81033-103-50

10 mL unit dose cups:
NDC: 81033-103-10
Case containing 100 unit dose cups of 10 mL:
NDC: 81033-103-51

STORAGE

Store at controlled temperature 15°C to 30°C (59°F to 86°F) [See USP]. Protect from light.

QUESTIONS OR COMMENTS

QUESTIONS OR COMMENTS
Call 1-833-537-4679

Packaged by:
Kesin Pharma
Oldsmar, FL 34677
Effective 10/2024
Revision 03

PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label

NDC: 81033-103-05

Dextromethorphan HBr and Guaifenesin Oral Solution

Delivers 10mg/100mg per 5mL

FOR INSTITUTIONAL USE ONLY

Store at 59°F to 86°F (15°C to 30°C)

PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label

NDC: 81033-103-10

Dextromethorphan HBr and Guaifenesin Oral Solution

Delivers 20mg/200mg per 10mL

FOR INSTITUTIONAL USE ONLY

Store at 59°F to 86°F (15°C to 30°C)

INGREDIENTS AND APPEARANCE

DEXTROMETHORPHAN HBR AND GUAIFENESIN ORAL SOLUTION 
dextromethorphan hbr and guaifenesin oral solution liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81033-103(NDC:84447-102)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
METHYLPARABEN (UNII: A2I8C7HI9T)
SORBITOL (UNII: 506T60A25R)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81033-103-50	100 in 1 CASE	12/02/2024
1	NDC: 81033-103-05	5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 81033-103-51	100 in 1 CASE	12/02/2024
2	NDC: 81033-103-10	10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	12/02/2024

Labeler - KESIN PHARMA CORPORATION (117447816)

Establishment
Name	Address	ID/FEI	Business Operations
Kesin Pharma Corporation		117447816	repack(81033-103)

Establishment
Name	Address	ID/FEI	Business Operations
Kesin Pharma Corporation		119132647	repack(81033-103)