DEXTROMETHORPHAN HBR AND GUAIFENESIN liquid

Dextromethorphan HBr and Guaifenesin by

Drug Labeling and Warnings

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

Drug Details [pdf]

Dextromethorphan HBr and Guaifenesin Oral Solution

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

ACTIVE INGREDIENT

• Active Ingredients – 5mL (1 teaspoonful): Purposes
• Guaifenesin 100 mg: Expectorant
• Dextromethorphan 5 mg: Cough Suppressant

Inactive Ingredients

Trisodium citrate Dihydrate, Citric Acid Anhydrous, USP Xanthan Gum Sodium Benzoate, NF Glycerin 99.7%, USP Propylene Glycol Sucralose Powder Sodium Saccharin, USP Sorbitol Solution 70%, Non-Crystallizable Sodium Artificial Mixed Berry Flavor Purified Water

Uses

▪ Temporarily relieves cough due to minor throat and bronchial irritations as my occur with a cold
▪ Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

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 and 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.

STOP USE

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.

PREGNANCY 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.

DOSAGE & ADMINISTRATION

Directions
▪ 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

SPL UNCLASSIFIED SECTION

Other information

• Each teaspoonful contains: sodium 4 mg
• Store at 20° - 25°C (68° - 77°F)
• Alcohol/sugar free
• Clear, mixed berry flavored solutions supplied in the following oral dosage forms: NDC: 81033-213-05 (unit dose cups of 5mL) and NDC: 81033-213-10 (unit dose cups of 10mL)

QUESTIONS

QUESTIONS OR COMMENTS
Call 1-833-537-4679

PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label

NDC: 81033-213-50

Dextromethorphan HBr and Guaifenesin Oral Solution

Delivers 5mg/100mg per 5mL

FOR INSTITUTIONAL USE ONLY

50 X 5 mL Unit Dose Cups

Store at 59°F to 86°F (15°C to 30°C)

PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label

NDC: 81033-213-51

Dextromethorphan HBr and Guaifenesin Oral Solution

Delivers 10mg/200mg per 10mL

FOR INSTITUTIONAL USE ONLY

50 X 10 mL Unit Dose Cups

Store at 59°F to 86°F (15°C to 30°C)

INGREDIENTS AND APPEARANCE

DEXTROMETHORPHAN HBR AND GUAIFENESIN 
dextromethorphan hbr and guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81033-213
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY (Mixed Berry Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81033-213-50	50 in 1 CARTON	11/15/2023
1		5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 81033-213-51	50 in 1 CARTON	11/15/2023
2		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	11/15/2023

Labeler - KESIN PHARMA CORPORATION (117447816)