NDC | 58809-198-60 |
Set ID | 4b2077b4-9d12-1fa0-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | GM Pharmaceuticals, Inc. |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Active Ingredients
- Purpose
-
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- cough due to minor 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 get to sleep
- nasal congestion due to a cold
-
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 an MAOI, ask a doctor or pharmacist before taking this product
- ASK DOCTOR
- WHEN USING
- Stop use and ask a doctor if:
- PREGNANCY OR BREAST FEEDING
- Keep out of reach of children.
- Directions
- Other information
- Inactive Ingredients
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
VANATAB DM
dextromethorphan hbr, guaifenesin, phenylephrine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58809-198 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 198 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 9 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength POLYSORBATE 20 (UNII: 7T1F30V5YH) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MENTHOL 1-PROPYLENE GLYCOL CARBONATE, (-)- (UNII: 2WL8FX4EEZ) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color white (white/off white) Score no score Shape OVAL Size 15mm Flavor Imprint Code 19 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58809-198-60 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/01/2017 Labeler - GM Pharmaceuticals, Inc. (793000860)