Label: AUROQUIL COLD AND FLU NIGHTTIME RELIEF- acetaminophen, doxylamine succinate, and dextromethorphan hbr solution
- NDC Code(s): 58602-136-16, 58602-136-18, 58602-136-20
- 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 16, 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
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product.
Allergy alert: acetaminophen may cause severe skin reactions.
Symptoms may include:- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
-
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- 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.
Overdose warning: Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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Directions
- take only as directed – see Overdose warning
- use dose cup or tablespoon (TBSP)
- do not exceed 4 doses (120 mL) (8 TBSP) per 24 hours
- mL = milliliter; TBSP = tablespoon
adults & children 12 years & 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® Cold & Flu*
NDC 58602-136-18
AuroQuil
COLD & FLU
Nighttime Relief
Each dose (per 30 mL) (2 TBSP) of oral solution contains:
650 mg - Acetaminophen USP (Pain reliever/fever reducer)
12.5 mg - Doxylamine succinate USP (Antihistamine)
30 mg - Dextromethorphan HBr USP (Cough suppressant)- Aches, Fever & Sore Throat
- Sneezing, Runny Nose
- Cough
Alcohol 10% 6 FL OZ (177 mL)
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (237 mL Bottle)
AUROHEALTH
Compare to the active ingredients
in Vicks® NyQuil® Cold & Flu*
NDC 58602-136-20
AuroQuil
COLD & FLU
Nighttime Relief
Each dose (per 30 mL) (2 TBSP) of oral solution contains:
650 mg - Acetaminophen USP (Pain reliever/fever reducer)
12.5 mg - Doxylamine Succinate USP (Antihistamine)
30 mg - Dextromethorphan HBr USP (Cough suppressant)- Aches, Fever & Sore Throat
- Sneezing, Runny Nose
- Cough
Alcohol 10% 8 FL OZ (237 mL)
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (355 mL Bottle)
AUROHEALTH
Compare to the active ingredients
in Vicks® NyQuil® Cold & Flu*
NDC 58602-136-16
AuroQuil
COLD & FLU
Nighttime Relief
Each dose (per 30 mL) (2 TBSP) of oral solution contains:
650 mg - Acetaminophen USP (Pain reliever/fever reducer)
12.5 mg - Doxylamine succinate USP (Antihistamine)
30 mg - Dextromethorphan HBr USP (Cough suppressant)
- Aches, Fever & Sore Throat
- Sneezing, Runny Nose
- Cough
Alcohol 10% 12 FL OZ (355 mL)
-
INGREDIENTS AND APPEARANCE
AUROQUIL COLD AND FLU NIGHTTIME RELIEF
acetaminophen, doxylamine succinate, and dextromethorphan hbr solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-136 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 30 mL 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 ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) 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) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) 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, MENTHOL Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-136-18 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/27/2015 09/01/2021 2 NDC:58602-136-20 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/27/2015 09/01/2021 3 NDC:58602-136-16 355 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(58602-136)