NDC | 58602-132-16, 58602-132-18, 58602-132-20 |
Set ID | 3fd3c799-1ae4-406d-9371-00a531fbe585 |
Category | Human OTC Drug Label |
Packager | Aurohealth LLC |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART341 |
- 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)