NDC | 58602-112-18, 58602-112-21 |
Set ID | 3a88f8e2-2292-4f0b-b046-5c96a58be974 |
Category | Human OTC Drug Label |
Packager | Aurohealth LLC |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Drug Facts
- Purposes
-
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
- for children under 12 years of age
- 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. Avoid foods or beverages that contain caffeine
- Ask a doctor before use if you have
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
-
Directions
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- mL = milliliter; tsp = teaspoon
- Adults and children 12 years and older: 20 mL (4 tsp) orally every 4 hours, not to exceed 6 doses in 24 hours
- Children under 12 years of age: do not use unless directed by a doctor
- Other information
- Inactive ingredients
- Questions or Comments
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle)
AUROHEALTH
NDC 58602-112-18
Compare to the active ingredients in
Mucinex® FAST-MAXTM
Severe Congestion & Cough*
MAXIMUM STRENGTH**AuroMucus
Fast Maximum
Severe Congestion & Cough
Each dose per 20 mL (4 tsp) of oral solution contains:
20 mg - Dextromethorphan HBr USP (Cough Suppressant)
400 mg - Guaifenesin USP (Expectorant)
10 mg - Phenylephrine HCl USP (Nasal Decongestant)
- Controls Cough
- Relieves Nasal & Chest Congestion
- Thins & Loosens Mucus
For Ages 12+ 6 FL OZ (177 mL)
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 9 FL OZ (266 mL Bottle)
AUROHEALTH
NDC 58602-112-21
Compare to the active ingredients in
Mucinex® FAST-MAXTM
Severe Congestion & Cough*
MAXIMUM STRENGTH**AuroMucus
Fast Maximum
Severe Congestion & Cough
Each dose per 20 mL (4 tsp) of oral solution contains:
20 mg – Dextromethorphan HBr USP (Cough Suppressant)
400 mg - Guaifenesin USP (Expectorant)
10 mg - Phenylephrine HCl USP (Nasal Decongestant)
- Controls Cough
- Relieves Nasal & Chest Congestion
- Thins & Loosens Mucus
For Ages 12+ 9 FL OZ (266 mL)
-
INGREDIENTS AND APPEARANCE
AUROMUCUS - FAST MAXIMUM SEVERE CONGESTION AND COUGH
dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-112 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 in 20 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg in 20 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 20 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) PINEAPPLE (UNII: 2A88ZO081O) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYL GALLATE (UNII: 8D4SNN7V92) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color BLUE Score Shape Size Flavor BERRY, PINEAPPLE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-112-18 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/18/2015 06/22/2022 2 NDC:58602-112-21 266 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/18/2015 06/22/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 07/18/2015 06/22/2022 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurohealth LLC 078728447 MANUFACTURE(58602-112)