AuroFlu Night Time Severe Cold and Cough Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME POTASSIUM ALCOHOL ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 PINEAPPLE GLYCERIN MALTITOL PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM Red Colored Liquid Uses temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation temporarily reduces fever

AuroFlu Night Time Severe Cold and Cough Acetaminophen, Diphenhydramine HCl and Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME POTASSIUM ALCOHOL ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 PINEAPPLE GLYCERIN MALTITOL PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM Red Colored Liquid

Mfr: OTC
FunFoxMeds bottle

Drug Facts

Composition & Profile

Active Ingredients
Drug Facts Active ingredients (in each 30 mL (2 TBSP)) Acetaminophen USP 650 mg Diphenhydramine HCl USP 25 mg Phenylephrine HCl USP 10 mg
Inactive Ingredients
Inactive ingredients acesulfame potassium alcohol anhydrous citric acid edetate disodium FD&C Blue no.1 FD&C Red #40 flavors glycerin maltitol solution propylene glycol purified water sodium benzoate sodium citrate Questions or comments? 1-855-274-4122 *This product is not manufactured or distributed by Novartis Consumer Health Inc. owner of the registered trademark Theraflu ® ExpressMax™ Nighttime Severe Cold & Cough. TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS BROKEN OR MISSING. Distributed by: Aurohealth LLC. 2572 Brunswick Pike Lawrenceville NJ 08648
Strengths
30 ml 650 mg 25 mg 10 mg
Quantities
5 ml 30 ml
Treats Conditions
Uses Temporarily Relieves These Symptoms Due To A Cold Minor Aches And Pains Minor Sore Throat Pain Headache Nasal And Sinus Congestion Runny Nose Sneezing Itchy Nose Or Throat Itchy Watery Eyes Due To Hay Fever Cough Due To Minor Throat And Bronchial Irritation Temporarily Reduces Fever

Identifiers & Packaging

Container Type BOTTLE
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8.3 FL OZ (245.5 mL Bottle) AUROHEALTH Compare to the active ingredients in Theraflu ® ExpressMax™ Nighttime Severe Cold & Cough* NDC 58602-161-33 AuroFlu Nighttime Severe Cold & Cough Maximum Strength Per 4 hour dose. Each dose (per 30 mL) of Syrup contains: 650 mg - ACETAMINOPHEN, USP (Pain Reliever/Fever Reducer) 25 mg - DIPHENHYDRAMINE HCl, USP (Cough Suppressant/Antihistamine) 10 mg - PHENYLEPHRINE HCl, USP (Nasal Decongestant) Nasal congestion Headache Sore throat pain Runny nose Body ache Cough Fever 8.3 FL OZ (245.5 mL) Berry Flavor Alcohol Content: 10% PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8.3 FL OZ (245.5 mL Bottle)

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8.3 FL OZ (245.5 mL Bottle) AUROHEALTH Compare to the active ingredients in Theraflu ® ExpressMax™ Nighttime Severe Cold & Cough* NDC 58602-161-33 AuroFlu Nighttime Severe Cold & Cough Maximum Strength Per 4 hour dose. Each dose (per 30 mL) of Syrup contains: 650 mg - ACETAMINOPHEN, USP (Pain Reliever/Fever Reducer) 25 mg - DIPHENHYDRAMINE HCl, USP (Cough Suppressant/Antihistamine) 10 mg - PHENYLEPHRINE HCl, USP (Nasal Decongestant) Nasal congestion Headache Sore throat pain Runny nose Body ache Cough Fever 8.3 FL OZ (245.5 mL) Berry Flavor Alcohol Content: 10% PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8.3 FL OZ (245.5 mL Bottle)

Overview

Uses temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation temporarily reduces fever

Indications & Usage

Uses temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation temporarily reduces fever

Dosage & Administration

Directions do not use more than directed measure the dose correctly using the enclosed dosing cup take every 4 hours in dosing cup provided, while symptoms persist do not take more than 5 doses (150 mL) (10 TBSP) in 24 hours unless directed by a doctor TBSP = Tablespoon, mL = milliliter Age Dose adults and children 12 years of age and over 30 mL (2 TBSP) children under 12 years of age do not use Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Warnings & Precautions
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 daily 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.
Purpose

Purposes Pain Reliever/Fever Reducer Antihistamine/Cough suppressant Nasal decongestant

Do Not Use

Do not use in a child under 12 years of age if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on the skin 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.

When Using

When using this product do not exceed recommended dosage 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

Stop Use & Ask a Doctor

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain, cough or nasal congestion gets worse or lasts more than 7 days 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

Keep this and all drugs out of the reach of children. In case of overdose, get medical help 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.

Storage & Handling

Other information each 30 mL contains: potassium 9 mg, sodium 15 mg Store at 20-25 o C (68-77 o F) TAMPER EVIDENT: Do not use if printed seal over cap is broken or missing


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