NDC | 58602-136-16, 58602-136-18, 58602-136-20 |
Set ID | 74fb4ff2-0bda-4e76-b846-b33cba2e5cf0 |
Category | Human OTC Drug Label |
Packager | Aurohealth LLC |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART341 |
- 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.
-
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)