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← See all AuroQuil COLD and FLU Nighttime Relief brands

AuroQuil COLD and FLU Nighttime Relief

Dosage form: solution
Ingredients: ACETAMINOPHEN 650mg in 30mL, DEXTROMETHORPHAN HYDROBROMIDE 30mg in 30mL, DOXYLAMINE SUCCINATE 12.5mg in 30mL
Labeler: Aurohealth LLC
NDC Code: 58602-136

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 Facts

Active ingredients (in each 30 mL dose cup)                   Purpose

Acetaminophen, USP 650 mg                                       Pain reliever/fever reducer
Dextromethorphan HBr, USP 30 mg                                       Cough suppressant
Doxylamine succinate, USP 12.5 mg                                                Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing

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
  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are
  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product
  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if
  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

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
  • each 30 mL dose cup contains: potassium 5 mg, sodium 38 mg
  • store at 20° to 25°C (68° to 77°F)

Inactive ingredients

acesulfame potassium, alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavors, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or Comments?

1-855-274-4122

Distributed by:
Aurohealth LLC.
2572 Brunswick Pike
Lawrenceville, NJ 08648

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)



 

AUROQUIL COLD AND FLU NIGHTTIME RELIEF 
acetaminophen, doxylamine succinate, and dextromethorphan hbr solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-136
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ALCOHOL 
ANHYDROUS CITRIC ACID 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
CHERRY 
MENTHOL, UNSPECIFIED FORM 
HIGH FRUCTOSE CORN SYRUP 
POLYETHYLENE GLYCOL 1500 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM CITRATE 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRY, MENTHOLImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:58602-136-18177 mL in 1 BOTTLE
2NDC:58602-136-20237 mL in 1 BOTTLE
3NDC:58602-136-16355 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/27/2015
Labeler - Aurohealth LLC (078728447)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurohealth LLC078728447MANUFACTURE(58602-136)

 
Aurohealth LLC

← See all AuroQuil COLD and FLU Nighttime Relief brands

Medically reviewed on Apr 4, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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