MAXIPHEN
-
guaifenesin and
phenylephrine hydrochloride tablet
MCR American Pharmaceuticals, 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.
----------
temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies:
Ask a doctor before use if you are taking sedatives or tranquilizers
Do not exceed recommended dosage.
Adults and children 12 years of age and over: | 1 tablet by mouth every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor |
Children 6 to under 12 years of age: | 1/2 tablet by mouth every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor |
NDC 58605-0422-01
100 tablets
Maxiphen
Expectorant • Nasal Decongestant
Each immediate-release tablet contains: | |
Guaifenesin | 400 mg |
Phenylephrine HCl | 10 mg |
This bottle is not to be dispensed to consumer.
Dispense in a tight light-resistant container with
a child-resistant cap.
Store at 59°-86°F (15°-30°C) [see USP
Controlled Room Temperature]
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.
MCR American
MAXIPHEN
guaifenesin and phenylephrine hydrochloride tablet |
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC MONOGRAPH FINAL | part341 | 03/31/2008 |
Labeler - MCR American Pharmaceuticals, Inc. (783383011) |
Establishment | |||
Name | Address | ID/FEI | Operations |
MCR American Pharmaceuticals, Inc. | 783383011 | MANUFACTURE |
Revised: 05/2011 MCR American Pharmaceuticals, Inc.