Drug Labeling and Warnings

Drug Details

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AUROQUIL SEVERE COLD AND FLU NIGHTTIME RELIEF - acetaminophen, phenylephrine hcl, doxylamine succinate and dextromethorphan hbr solution 
Aurohealth LLC

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.

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Drug Facts

Active ingredients (in each 30 mL dose cup)                             Purpose

Acetaminophen USP 650 mg .............................................. Pain reliever/fever reducer
Dextromethorphan HBr USP 20 mg ............................................... Cough suppressant
Doxylamine succinate USP 12.5 mg ........................................................ Antihistamine
Phenylephrine HCl USP 10 mg ...................................................... Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • cough to help you sleep
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • runny nose & sneezing
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage

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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult 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
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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

  • you get nervous, dizzy or sleepless
  • pain, nasal congestion, 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 directed 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 4 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: sodium 95 mg
  • store at 20° to 25°C (68° to 77°F)

Inactive ingredients

anhydrous citric acid, flavors, FD&C Blue no. 1, FD&C Red no. 40, glycerin, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

Questions or Comments?

1-855-274-4122

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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (237 mL Bottle)

AUROHEALTH

Compare to the active
ingredients in the Vicks® NyQuil®
SEVERE Cold & Flu Relief Liquid*

NDC: 58602-148-20

Maximum Strength

AuroQuil
SEVERE
COLD & FLU
Nighttime Relief

Each dose (per 30 mL) (2 TBSP) of oral solution contains:
650 mg - Acetaminophen USP (Pain reliever/fever reducer)
10 mg – Phenylephrine HCl USP (Nasal decongestant)
12.5 mg - Doxylamine succinate USP (Antihistamine)
20 mg - Dextromethorphan HBr USP (Cough suppressant)


  • Headache, Fever, Sore Throat, Minor Aches & Pains
  • Nasal/Sinus Congestion & Sinus Pressure
  • Sneezing, Runny Nose
  • Cough

Berry Flavor                             8 FL OZ (237 mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 8 FL OZ (237 mL Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL Bottle)

AUROHEALTH

Compare to the active
ingredients in the Vicks® NyQuil®
SEVERE Cold & Flu Relief Liquid*

NDC: 58602-148-16

Maximum Strength

AuroQuil
SEVERE
COLD & FLU
Nighttime Relief

Each dose (per 30 mL) (2 TBSP) of oral solution contains:
650 mg - Acetaminophen USP (Pain reliever/fever reducer)
10 mg – Phenylephrine HCl USP (Nasal decongestant)
12.5 mg - Doxylamine succinate USP (Antihistamine)
20 mg - Dextromethorphan HBr USP (Cough suppressant)


  • Headache, Fever, Sore Throat, Minor Aches & Pains
  • Nasal/Sinus Congestion & Sinus Pressure
  • Sneezing, Runny Nose
  • Cough

Berry Flavor                             12 FL OZ (354 mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL Bottle)

AUROQUIL SEVERE COLD AND FLU NIGHTTIME RELIEF 
acetaminophen, phenylephrine hcl, doxylamine succinate and dextromethorphan hbr solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58602-148
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
BERRY (UNII: FV3431923Z)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorBERRY (Prosweet) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58602-148-20237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/31/2015
2NDC: 58602-148-16354 mL in 1 BOTTLE; Type 0: Not a Combination Product05/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/31/2015
Labeler - Aurohealth LLC (078728447)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurohealth LLC078728447MANUFACTURE(58602-148)

Revised: 4/2016
 
Aurohealth LLC


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