Aurophen cold multi-symptom severe liquid

Drug facts

Active ingredients (in each15 mL)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/ fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses

  • for the temporary relief of the following cold/flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • cough
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever

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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not exceed recommended dose

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • 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: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

  • do not take more than directed (see overdose warning)
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • mL = milliliter
adults and children 12 years and over
  • take 30 mL in the dosing cup provided every 4 hours while symptoms last
  • do not take more than 150 mL in 24 hours, unless directed by a doctor
children under 12 years
ask a doctor

Other information

  • each 15 mL contains: sodium 5 mg
  • store at 20-25C (68-77F). Do not refrigerate.
  • do not use if printed shrinkband is missing or broken.
  • see back label for lot number and expiration date

Inactive ingredients

alcohol, anhydrous citric acid, FD&C blue no.1, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose.

Questions or comments?

1-855-274-4122

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

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

Ingredients and appearance - Product information

Aurophen cold multi-symptom severe liquid- Acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-128
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 325 mgin 15 mL
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 10 mgin 15 mL
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 200 mgin 15 mL
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 5 mgin 15 mL

Inactive Ingredients

Ingredient Name Code
Alcohol ( UNII: 3K9958V90M)
Anhydrous citric acid ( UNII: XF417D3PSL)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Peppermint ( UNII: V95R5KMY2B)
Glycerin ( UNII: PDC6A3C0OX)
Menthol, unspecified form ( UNII: L7T10EIP3A)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Sodium benzoate ( UNII: OJ245FE5EU)
Sorbitol ( UNII: 506T60A25R)
Sucralose ( UNII: 96K6UQ3ZD4)

Product Characteristics

Color BLUE (Blue to greenish blue) Flavor PEPPERMINT

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part341 USA

Labeler - Aurohealth LLC( 078728447)

Establishment

Name ID/FEI Business Operations
Aurohealth LLC 078728447 MANUFACTURE( 58602-128)

Package label-principal display panel 8 fl oz (240 ml bottle)

AUROHEALTH
NDC 58602-128-20

Compare to the active ingredients in

TYLENOL ®COLD MULTI-SYMPTOM SEVERE

Cool Blast

AUROPHEN

COLD MULTI-SYMPTOM SEVERE

For Adults

Acetaminophen - Pain Reliever/Fever Reducer

Phenylephrine HCl - Nasal Decongestant

Dextromethorphan HBr - Antitussive

Guaifenesin - Expectorant

  • Headache, Fever, Sore Throat
  • Nasal Congestion
  • Cough
  • Clears Out Chest Mucus

Alcohol 0.5%

8 FL OZ

(240 mL)

Liquid

Do not use if printed shrinkband is missing or broken.