Drug Labeling and Warnings

Drug Details

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AUROQUIL SEVERE COLD AND FLU DAYTIME RELIEF - acetaminophen, phenylephrine hcl, dextromethorphan hbr and guaifenesin 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 15 mL tablespoon)                           Purpose

Acetaminophen USP 325 mg .............................................. Pain reliever/fever reducer
Dextromethorphan HBr USP 10 mg ............................................... Cough suppressant
Guaifenesin USP 200 mg .......................................................................... Expectorant
Phenylephrine HCl USP 5 mg ........................................................ Nasal decongestant

Uses


  • temporarily relieves common cold/flu symptoms:
  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 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.

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product,

do not use more than directed.

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • 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 (60 mL) (4 TBSP) per 24 hours
  • mL = milliliter; TBSP = tablespoon
adults & children 12 years & over
30 mL (2 TBSP) every 4 hours
children 6 to under 12 years
15 mL (1 TBSP) every 4 hours
children 4 to under 6 years
ask a doctor
children under 4 years
do not use
  • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Other information

  • each 15 mL tablespoon contains: sodium 49 mg
  • store at 20° to 25°C (68° to 77°F)

Inactive ingredients

anhydrous citric acid, flavor, FD&C yellow No. 6, 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® DayQuil®
SEVERE Cold & Flu Relief Liquid*

NDC: 58602-149-20

Maximum Strength

AuroQuil
SEVERE
COLD & FLU
Daytime Relief

Each dose (per 15 mL) (1 TBSP) of oral solution contains:
325 mg - Acetaminophen USP (Pain reliever/fever reducer)
5 mg – Phenylephrine HCl USP (Nasal decongestant)
10 mg - Dextromethorphan HBr USP (Cough suppressant)
200 mg - Guaifenesin USP (Expectorant)


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

Non-Drowsy
Alcohol Free
                             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® DayQuil®
SEVERE Cold & Flu Relief Liquid*

NDC: 58602-149-16

Maximum Strength

AuroQuil
SEVERE
COLD & FLU
Daytime Relief

Each dose (per 15 mL) (1 TBSP) of oral solution contains:
325 mg - Acetaminophen USP (Pain reliever/fever reducer)
5 mg – Phenylephrine HCl USP (Nasal decongestant)
10 mg - Dextromethorphan HBr USP (Cough suppressant)
200 mg - Guaifenesin USP (Expectorant)


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

Non-Drowsy
Alcohol Free                                 12 FL OZ (354 mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL Bottle)

AUROQUIL SEVERE COLD AND FLU DAYTIME RELIEF 
acetaminophen, phenylephrine hcl, dextromethorphan hbr and guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58602-149
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
RASPBERRY (UNII: 4N14V5R27W)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
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
ColorORANGE (Orange to Reddish Orange) Score    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58602-149-20237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2015
2NDC: 58602-149-16354 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/01/2015
Labeler - Aurohealth LLC (078728447)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurohealth LLC078728447MANUFACTURE(58602-149)

Revised: 4/2016
 
Aurohealth LLC


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