GUAIFENESIN AND DEXTROMETHORPHAN ORAL SOLUTION- guaifenesin dextromethorphan hydrobromide oral solution solution
GUAIFENESIN AND DEXTROMETHORPHAN ORAL SOLUTION- guaifenesin dextromethorphan hydrobromide oral solution solution
Major Pharmaceuticals
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.
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Major Pharmaceuticals
Unit Dose OTC Monograph
Guaifenesin DM 200/20 mg/ 10 mL
Guaifenesin DM 100/10 mg/ 5 mL
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
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 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 AND DEXTROMETHORPHAN ORAL SOLUTION
guaifenesin dextromethorphan hydrobromide oral solution solution |
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| GUAIFENESIN AND DEXTROMETHORPHAN ORAL SOLUTION
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| 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) | |