GUAIFENESIN AND DEXTROMETHORPHAN ORAL SOLUTION- guaifenesin dextromethorphan hydrobromide oral solution solution

Guaifenesin and Dextromethorphan Oral Solution by

Drug Labeling and Warnings

Guaifenesin and Dextromethorphan Oral Solution by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, Plastikon Healthcare, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/5 mL Cup

NCD 0904-6844-70

Guaifenesin and Detromethorphan Oral Solution

100-10 mg/5 mL

Delivers 5 mL

See Insert

For Institutional Use Only

MAJOR® PHARMACEUTICALS

Livonia, MI 48152

Sugar Free - Alcohol Free

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/5 mL cup

Directions

• do not exceed the maximum recommended daily dose in a 24 hour period
• shake well before use

• Age (yr):

  Dose (mL)

• adults and children 12 years and over:

  10 mL every 4 hours or 15 mL every 6 hours

  Max dose is 60 mL in 24 hr

• children 6 years to under 12 years:

  5 mL every 4 hours

  Max does is 30 mL in 24 hr

• under 6 years:

  Ask a doctor

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/5 mL

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

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/5 mL

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/5 mL

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping the MAOI drug.

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

_________________________________________________________________

Ask a doctor or pharmacist before use if you are taking any other drug. ___________________________________________________________________

Stop use and ask a doctor if

• your cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache.

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/ 5 mL

Inactive ingredients citric acid, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol, sucralose, xanthan gum

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/ 5 mL

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/5 mL

Active ingredients (in each 5 mL cup)

Guaifenesin 100 mg

Dextromethorphan hydrobromide 10 mg

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/5 mL

Purpose

Expectorant

Cough Suppressant

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/ 5 mL

Other information

• each 5 mL contains: sodium 20 mg
• store at 20-25°C (68-77°F)
• protect from excessive moisture
• do not use if lid seal is open or damaged
• sugar free, dye free, alcohol free
• see bottom of cup for lot number and expiration date

Guaifenesin Dextromethorphan hydrobromide 200/20 mg/10mL

NCD 0904-6980-72

Guaifenesin and Detromethorphan Oral Solution

200-20 mg/10 mL

Delivers 10 mL

See Insert

For Institutional Use Only

MAJOR® PHARMACEUTICALS

Livonia, MI 48152

Sugar Free - Alcohol Free

Guaifenesin Dextromethorphan hydrobromide 200/20 mg/ 10 mL

Directions

• do not exceed the maximum recommended daily dose in a 24 hour period
• shake well before use

• Age (yr):

  Dose (mL)

• adults and children 12 years and over:

  10 mL every 4 hours

  Max dose is 60 mL in 24 hr

• children under 12 years:

  Ask a doctor

Guaifenesin Dextromethorphan hydrobromide 200/20 mg/10 mL

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

Guaifenesin Dextromethorphan hydrobromide 200/20 mg/10 mL

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping the MAOI drug.

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

_________________________________________________________________

Ask a doctor or pharmacist before use if you are taking any other drug. ___________________________________________________________________

• Stop use and ask a doctor if
• your cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache.
• you are hypersensitive to any of the ingredients

___________________________________________________________________

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

Guaifenesin Dextromethorpan hydrobromide 200/20 mg/10 mL

Inactive ingredients citric acid, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol, sucralose, xanthan gum

Guaifenesin Dextromethorphan hydrobromide 200/20 mg/10 mL

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Guaifenesin Dextromethorphan hydrobromide 200/20 mg/10 mL

Active ingredients (in each 10 mL cup)

Guaifenesin 200 mg

Dextromethorphan hydrobromide 20 mg

Guaifenesin Dextromethorphan hydrobromide 200/20 mg/ 10 mL

Purpose

Expectorant

Cough Suppressant

Guaifenesin Dextromethorphan hydrobromide 200/20 mg/ 10 mL

Other information

• each 10 mL contains: sodium 40 mg
• store at 20-25°C (68-77°F)
• protect from excessive moisture
• do not use if lid seal is open or damaged
• sugar free, dye free, alcohol free
• see bottom of cup for lot number and expiration date

Guaifenesin Dextromethorphan hydrobromide 200/20 mg/10 mL

INGREDIENTS AND APPEARANCE

GUAIFENESIN AND DEXTROMETHORPHAN ORAL SOLUTION 
guaifenesin dextromethorphan hydrobromide oral solution solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6844
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
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6844-70	10 in 1 CARTON	09/20/2019
1		10 in 1 TRAY
1		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 final	part341	09/20/2019

GUAIFENESIN AND DEXTROMETHORPHAN ORAL SOLUTION 
guaifenesin dextromethorphan hydrobromide oral solution solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6980
Route of Administration	ORAL

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

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

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6980-72	10 in 1 CARTON	09/20/2019
1		10 in 1 TRAY
1		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 final	part341	09/20/2019

Labeler - Major Pharmaceuticals (191427277)

Registrant - Plastikon Healthcare, LLC (041717941)

Establishment
Name	Address	ID/FEI	Business Operations
Plastikon Healthcare, LLC		041717941	manufacture(0904-6980, 0904-6844)