Label: MUCUS- guaifenesin tablet, extended release
-
Contains inactivated NDC Code(s)
NDC Code(s): 63868-389-20 - Packager: CHAIN DRUG MARKETING ASSOCIATION INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 14, 2018
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 extended-release tablet)
- Purpose
- Uses
-
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
- •
- do not crush, chew, or break tablet
- •
- take with a full glass of water
- •
- this product can be administered without regard for the timing of meals
- •
- adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
- •
- children under 12 years of age: do not use
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 600 mg Tablet Blister Pack Carton
-
INGREDIENTS AND APPEARANCE
MUCUS
guaifenesin tablet, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-389 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 600 mg Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color WHITE Score no score Shape OVAL Size 16mm Flavor Imprint Code Mxeunic;600 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-389-20 1 in 1 CARTON 02/08/2018 1 20 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021282 02/08/2018 Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774) Establishment Name Address ID/FEI Business Operations RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD 230780363 MANUFACTURE(63868-389)