Label: AUROQUIL COUGH NIGHTTIME COUGH RELIEF- dextromethorphan hbr and doxylamine succinate solution
- NDC Code(s): 58602-132-16, 58602-132-18, 58602-132-20
- 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
- PURPOSE
- Uses
- 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.
- to make a child sleep
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
-
Directions
- use dose cup or tablespoon (TBSP)
- do not exceed 4 doses (120 mL) (8 TBSP) per 24 hours
- mL = milliliter; TBSP = tablespoon
adults and children 12 years and over
30 mL (2 TBSP) every 6 hours
children 4 to under 12 years
ask a doctor
children under 4 years
do not use
- when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
- Other information
- Inactive ingredients
- Questions or Comments?
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 6 FL OZ (177 mL Bottle)
AUROHEALTH
Compare to the active ingredients
in Vicks® NyQuil® Cough*
NDC 58602-132-20
AuroQuil
COUGH
Nighttime Cough Relief
Each dose (per 30 mL) (2 TBSP) of oral solution contains:
30 mg - Dextromethorphan HBr USP (Cough suppressant)
12.5 mg - Doxylamine succinate USP (Antihistamine)
- Cough
- Sneezing, Runny Nose
Alcohol 10% Cherry Flavor 6 FL OZ (177 mL)
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (236 mL Bottle)
AUROHEALTH
Compare to the active ingredients
in Vicks® NyQuil® Cough*
NDC 58602-132-18
AuroQuil
COUGH
Nighttime Cough Relief
Each dose (per 30 mL) (2 TBSP) of oral solution contains:
30 mg - Dextromethorphan HBr USP (Cough suppressant)
12.5 mg - Doxylamine succinate USP (Antihistamine)
- Cough
- Sneezing, Runny Nose
Alcohol 10% Cherry Flavor 8 FL OZ (236 mL)
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL Bottle)
AUROHEALTH
Compare to the active ingredients
in Vicks® NyQuil® Cough*
NDC 58602-132-16
AuroQuil
COUGH
Nighttime Cough Relief
Each dose (per 30 mL) (2 TBSP) of oral solution contains:
30 mg - Dextromethorphan HBr USP (Cough suppressant)
12.5 mg - Doxylamine succinate USP (Antihistamine)
- Cough
- Sneezing, Runny Nose
Cherry Flavor
Alcohol 10% 12 FL OZ (354 mL)
-
INGREDIENTS AND APPEARANCE
AUROQUIL COUGH NIGHTTIME COUGH RELIEF
dextromethorphan hbr and doxylamine succinate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-132 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 30 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg in 30 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) CHERRY (UNII: BUC5I9595W) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) Product Characteristics Color RED Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-132-20 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/27/2015 09/01/2021 2 NDC:58602-132-18 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/27/2015 09/01/2021 3 NDC:58602-132-16 354 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/27/2015 09/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 07/27/2015 09/01/2021 Labeler - Aurohealth LLC (078728447) Registrant - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurohealth LLC 078728447 MANUFACTURE(58602-132)