Aurophen cold multi symptom liquid

Drug facts

Active ingredients (in each15 mL)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant

Uses

  • temporarily relieves these common cold/flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • runny nose and sneezing
    • cough
    • sinus congestion and pressure
  • helps clear nasal passages
  • relieves cough to help you sleep
  • 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
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • persistent or chronic cough such as occurs with smoking, asthma 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
  • taking sedatives or tranquilizers

When using this product

  • do not exceed recommended dose
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

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 #1, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

Questions or comments?

1-855-274-4122

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN


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

Ingredients and appearance - Product information

Aurophen cold multi symptom liquid- Acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 58602-127
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
Doxylamine succinate ( UNII: V9BI9B5YI2)( Doxylamine - UNII: 95QB77JKPL ) 6.25 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( 58602-127)

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

AUROHEALTH

NDC 58602-127-20

Compare to the active
ingredients in TYLENOL ®
COLD MULTI-SYMPTOM Liquid night time cool burst TM*

NIGHT TIME

Cool Blast

AUROPHEN

COLD MULTI-SYMPTOM

For Adults

Acetaminophen - Pain Reliever/Fever Reducer

Phenylephrine HCl - Nasal Decongestant

Dextromethorphan HBr - Antitussive

Doxylamine Succinate - Antihistamine

  • Headache, Fever, Sore Throat
  • Nasal Congestion
  • Cough
  • Runny Nose Alcohol 0.5%

8 FL OZ

(240 mL)

Liquid

Do not use if printed shrinkband is missing or broken.