Label: MUCUS RELIEF CHEST CONGESTION- guaifenesin tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 50436-6815-1 - Packager: Unit Dose Services
- This is a repackaged label.
- Source NDC Code(s): 0904-6815
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 July 18, 2019
If you are a consumer or patient please visit this version.
- 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
- cough accompanied by too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- HOW SUPPLIED
- MUCUS RELIEF CHEST CONGESTION (GUAIFENESIN) TABLET, FILM COATED
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INGREDIENTS AND APPEARANCE
MUCUS RELIEF CHEST CONGESTION
guaifenesin tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50436-6815(NDC:0904-6815) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color BLUE Score 2 pieces Shape ROUND Size 13mm Flavor Imprint Code 44;532 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50436-6815-1 60 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 10/31/2018 Labeler - Unit Dose Services (831995316) Establishment Name Address ID/FEI Business Operations Unit Dose Services 831995316 REPACK(50436-6815) , RELABEL(50436-6815)