Label: MUCUS RELIEF- guaifenesin tablet
- NDC Code(s): 68210-0116-1
- Packager: SPIRIT PHARMACEUTICALS LLC
- 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 January 18, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each caplet)
- 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?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 15 Caplet Bottle Carton
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INGREDIENTS AND APPEARANCE
MUCUS RELIEF
guaifenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-0116 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE K30 (UNII: U725QWY32X) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape CAPSULE Size 17mm Flavor Imprint Code EB Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-0116-1 1 in 1 CARTON 03/15/2018 01/12/2022 1 15 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/15/2018 Labeler - SPIRIT PHARMACEUTICALS LLC (179621011) Establishment Name Address ID/FEI Business Operations ELYSIUM PHARMACEUTICALS LTD 915664486 manufacture(68210-0116)