Label: AUROMUCUS - FAST MAXIMUM SEVERE CONGESTION AND COUGH- dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride solution
- NDC Code(s): 58602-112-18, 58602-112-21
- Packager: Aurohealth 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 November 13, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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)