DEXTROMETHORPHAN HBR. AND GUAIFENESIN solution

Dextromethorphan HBr. and Guaifenesin by

Drug Labeling and Warnings

Dextromethorphan HBr. and Guaifenesin by is a Otc medication manufactured, distributed, or labeled by Rising Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

DOSAGE & ADMINISTRATION

Directions

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

20 mg-200 mg/10 mL

age	dose
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

• age: dose
• Children under 6 years of age: Do not use
• Children 6 to under 12 years of age: 5 mL (1 unit dose) every 4 hours
• Adults and children over 12 years of age: 10 mL (2 unit dose) every 4 hours

OTHER SAFETY INFORMATION

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 INGREDIENT

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

HOW SUPPLIED

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

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

Case Label    NDC: 57237-312-51

20 mg-200 mg/10 mL

Lid Label       NDC  57237-313-01

Case Label    NDC  57237-313-18

INGREDIENTS AND APPEARANCE

DEXTROMETHORPHAN HBR. AND GUAIFENESIN 
dextromethorphan hbr. and guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57237-312
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57237-312-51	100 in 1 BOX, UNIT-DOSE	06/12/2023
1	NDC: 57237-312-05	5 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	M012.85	06/12/2023

DEXTROMETHORPHAN HBR. AND GUAIFENESIN 
dextromethorphan hbr. and guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57237-313
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57237-313-18	80 in 1 BOX, UNIT-DOSE	06/12/2023
1	NDC: 57237-313-01	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	M012.85	06/12/2023

Labeler - Rising Pharma Holdings, Inc. (116880195)