DEXTROMETHORPHAN HBR AND GUAIFENESIN- dextromethorphan hbr and guaifenesin liquid 
KESIN PHARMA CORPORATION

----------

Dextromethorphan HBr and Guaifenesin Oral Solution

Dextromethorphan HBr and Guaifenesin Oral Solution

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

 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 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.

If pregnant or breast-feeding, ask 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.

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

AgeDose
adults and children 12 years and over10mL (2 teaspoonful) every 4 hours
children 6 to under 12 years of age5mL (1 teaspoonful) every 4 hours
children 2 to under 6 years of age2.5mL (1/2 teaspoonful) every 4 hours
children under 2 yearsconsult a doctor

Other information

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)

5 mL cup label

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)

10 mL cup label

DEXTROMETHORPHAN HBR AND GUAIFENESIN 
dextromethorphan hbr and guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81033-213
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorBERRY (Mixed Berry Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81033-213-5050 in 1 CARTON11/15/2023
15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2NDC:81033-213-5150 in 1 CARTON11/15/2023
210 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01211/15/2023
Labeler - KESIN PHARMA CORPORATION (117447816)

Revised: 11/2023
Document Id: 06a6a831-218c-4c29-a43b-2afafc16e560
Set id: 753aaffd-f341-4cb3-b611-303ec7ca9aa8
Version: 1
Effective Time: 20231114
 
KESIN PHARMA CORPORATION