NDC | 69168-543-26, 69168-543-60 |
Set ID | 99fc1c8b-5dd9-4c24-b866-7f776dfb2d84 |
Category | HUMAN OTC DRUG LABEL |
Packager | Allegiant Health |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART341 |
- Active ingredient (in each tablet)
- Purpose
-
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways and make coughs more productive
- temporarily relieves:
- cough due to minor sore throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you sleep
-
Warnings
Do not use
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains am MAOI, ask a doctor or pharmacist before taking this product.
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
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
MUCUS RELIEF DM IMMEDIATE RELEASE
dextromethorphan hbr and guaifenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-543 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color WHITE Score no score Shape CAPSULE Size 16mm Flavor Imprint Code AZ345 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-543-26 1 in 1 CARTON 12/23/2014 1 20 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:69168-543-60 1 in 1 CARTON 12/23/2014 2 60 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 12/23/2014 Labeler - Allegiant Health (079501930)