AuroFlu Night Time Severe Cold and Cough Warming Relief
Dosage form: syrup
Ingredients: ACETAMINOPHEN 325mg in 15mL, DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg in 15mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 15mL
Labeler: Aurohealth LLC
NDC Code: 58602-140
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.
Active Ingredient (in each dose cup 15 mL)
Acetaminophen USP 325 mg
Diphenhydramine HCl USP 12.5 mg
Phenylephrine HCI USP 5 mg
Fever Reducer/Pain Reliever
- temporarily relieves
- minor aches and pains
- minor sore throat pain
- nasal and sinus congestion
- cough due to minor throat and bronchial irritation
- runny nose
- itchy, watery eyes
- itchy nose or throat
- temporarily reduces fever
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 doses (180 mL) in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers.
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.
- to make a child sleepy
- if you are on a sodium-restricted diet
- 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 two 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.
- with any other product containing diphenhydramine, even one used on skin
- with any other acetaminophen containing products. This may lead to an overdose, which may cause liver damage. (see overdose warning)
- heart disease
- thyroid disease
- high blood pressure
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
- cough accompanied by excessive phlegm (mucus)
- trouble urinating due to enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
- do not use more than directed (see overdose warning)
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
- redness or swelling is present
- you get nervous, dizzy or sleepless
- pain, cough or nasal congestion gets worse or lasts more than7 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting
- 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.
Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- do not exceed recommended dosage (see overdose warning)
- do not use in infants
| adults and children 12 years and over|| 30 mL (2 dose cups) (1fl oz) every 4 hours
| children 4 years to under 12 years|| do not use unless directed by a doctor
| children under 4 years
|| do not use
| Do not take more than 6 doses (12 dose cups) (180 mL) (6 fl oz) in 24 hours
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
- sodium content per 15 mL: 7.09 mg
- potassium content per 15 mL: 4.66 mg
- store at 20-25oC (68-77oF)
- TAMPER EVIDENT: Do not use if printed seal over cap is broken or missing
- see back panel for lot number and expiration date
acesulfame potassium, alcohol, anhydrous citric acid, edetate disodium, FD&C Blue No.1, FD&C Red # 40, flavor, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate
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*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Theraflu®.
Failure to follow the drug facts warnings could result in serious consequences.
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Compare to the active
ingredients in Theraflu®
Warming Relief Nighttime*
Night Time Severe
Cold & Cough Warming Relief
Each dose (per 15 mL) of Syrup contains:
325 mg - ACETAMINOPHEN
(Fever Reducer/Pain Reliever)
12.5 mg - DIPHENHYDRAMINE HCl
5 mg - PHENYLEPHRINE HCl
- Nasal congestion
- Runny Nose
- Body ache
- Sore throat
|AUROFLU NIGHT TIME SEVERE COLD AND COUGH WARMING RELIEF
acetaminophen, diphenhydramine hcl and phenylephrine hcl syrup
|Labeler - Aurohealth LLC (078728447)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.