Label: GUAIFENESIN tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 49349-511-02 - Packager: REMEDYREPACK INC.
- This is a repackaged label.
- Source NDC Code(s): 0904-5154
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated August 1, 2017
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each immediate-release tablet)
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough accompanied by too much phlegm (mucus)
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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PRINCIPAL DISPLAY PANEL
DRUG: Guaifenesin
GENERIC: Guaifenesin
DOSAGE: TABLET
ADMINSTRATION: ORAL
NDC: 49349-511-02
COLOR: pink
SHAPE: ROUND
SCORE: No score
SIZE: 10 mm
IMPRINT: 44;588
PACKAGING: 30 in 1 BLISTER PACK
ACTIVE INGREDIENT(S):
- GUAIFENESIN 200mg in 1
INACTIVE INGREDIENT(S):
- FD&C RED NO. 40
- MAGNESIUM STEARATE
- STEARIC ACID
- POVIDONE
- CELLULOSE, MICROCRYSTALLINE
- MALTODEXTRIN
- SILICON DIOXIDE
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INGREDIENTS AND APPEARANCE
GUAIFENESIN
guaifenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49349-511(NDC:0904-5154) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) FD&C RED NO. 40 (UNII: WZB9127XOA) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color pink (dark) Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;588 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49349-511-02 30 in 1 BLISTER PACK; Type 0: Not a Combination Product 08/12/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/12/2010 Labeler - REMEDYREPACK INC. (829572556)