DEXTROMETHORPHAN HBR. AND GUAIFENESIN- dextromethorphan hbr. and guaifenesin solution 
Rising Pharma Holdings, Inc.

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

----------

DRUG FACTS

10 mg-100 mg/5 mL -

Active ingredient per 5 mL (1 unit dose) 

Dextromethorphan HBr. 10 mg

Guaifenesin 100 mg

20 mg-200 mg/10 mL -

Active ingredient per 10 mL (1 unit dose)    

Dextromethorphan HBr. 20 mg

Guaifenesin 200 mg

Purpose

Cough Suppressant

Expectorant

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 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 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

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. These could be signs of a serious condition.

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

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

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

20 mg-200 mg/10 mL

agedose
Children under 12 years of age

Do not use

Adults and children over 12 years of age

10 mL (1 unit dose) every 4 hours

10 mg-100 mg/5 mL

agedose
Children under 6 years of ageDo not use
Children 6 to under 12 years of age5 mL (1 unit dose) every 4 hours
Adults and children over 12 years of age10 mL (2 unit dose) every 4 hours

Other Information
•   store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

•   do not use if lid is torn or broken

Inactive Ingredients citric acid, FD&C red#40, flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose.

NDC Information -

Each 5 mL of Guaifenesin Syrup and Dextromethorphan contains Guaifenesin 100mg and Dextromethorphan Hydrobromide 10mg and is supplied in the following oral dosage forms:

NDC 57237-312-05  unit dose cup 5mL
NDC 57237-312-51 (100 x 5 mL) unit-dose cups


Each 10 mL of Guaifenesin Syrup and Dextromethorphan contains Guaifenesin 200mg and Dextromethorphan Hydrobromide 20mg and is supplied in the following oral dosage forms:

NDC 57237-313-01 unit dose cup 10mL
NDC 57237-313-18 (80 x 10 mL) unit-dose cups

Questions or comments? Call 1-844-474-7464

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Issued: 04/2023

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10 mg-100 mg/5 mL

Lid Label       NDC 57237-312-05

Guai-Dextro-lid-label-5ml

Case Label    NDC 57237-312-51

Guai-Dextro-case-label-5ml

20 mg-200 mg/10 mL

Lid Label       NDC  57237-313-01

Guai-Dextro-lid-label-10ml

Case Label    NDC  57237-313-18

Guai-Dextro-case-label-10ml

DEXTROMETHORPHAN HBR. AND GUAIFENESIN 
dextromethorphan hbr. and guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-312
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57237-312-51100 in 1 BOX, UNIT-DOSE06/12/2023
1NDC:57237-312-055 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 finalpart34106/12/2023
DEXTROMETHORPHAN HBR. AND GUAIFENESIN 
dextromethorphan hbr. and guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-313
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57237-313-1880 in 1 BOX, UNIT-DOSE06/12/2023
1NDC:57237-313-0110 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 finalpart34106/12/2023
Labeler - Rising Pharma Holdings, Inc. (116880195)

Revised: 8/2023
Document Id: 89958dcf-99cf-4c41-bc16-480e87e02eee
Set id: e463e60f-d0db-4ee7-9713-ddf25aa38a43
Version: 2
Effective Time: 20230814
 
Rising Pharma Holdings, Inc.