GUAIFENESIN 400
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guaifenesin tablet
Breckenridge Pharmaceutical, Inc.
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Guaifenesin 400Drug Facts
Guaifenesin ....................... 400 mg
Expectorant
Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Stop use and ask doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
If pregnant or breast-feeding, ask a health professional before use.
Keep this and all medications out of the reach of children. In case of accidental overdose seek professional assistance or contact a poison control center immediately.
Croscarmellose Sodium, Hypromellose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Stearic Acid.
All prescription substitutions using this product shall be pursuant to state statutes as applicable.
This is not an Orange Book product.
To Report A Serious Adverse Event Contact: (800) 367-3395
Distributed by:
Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487
Manufactured by:
Provident Pharmaceuticals, LLC
Colorado Springs, CO 80919
PL 281
Iss: 04/08
Breckenridge
Pharmaceutical, Inc.
NDC 51991-606-01
Guaifenesin 400
Tablets
Expectorant
Each immediate-release tablet contains:
Guaifenesin ................... 400 mg
100 TABLETS
DO NOT USE IF SAFETY SEAL BAND IS
BROKEN OR MISSING FROM THE BOTTLE.
GUAIFENESIN 400
guaifenesin tablet |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph final | part341 | 05/01/2008 | 06/30/2011 |
Labeler - Breckenridge Pharmaceutical, Inc. (150554335) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Provident Pharmaceuticals, LLC | 171901445 | MANUFACTURE |