Severe Cold and Flu Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ALCOHOL ANHYDROUS CITRIC ACID D&C YELLOW NO. 10 EDETATE DISODIUM FD&C GREEN NO. 3 FD&C YELLOW NO. 6 GLYCERIN PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE SORBITOL SUCRALOSE Uses temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion and pressure • minor aches and pains • headache • fever • sore throat • runny nose and sneezing • cough due to minor throat and bronchial irritation • cough to help you sleep • reduces swelling of nasal passages • promotes nasal and/or sinus drainage • temporarily restores freer breathing through the nose

Severe Cold and Flu Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ALCOHOL ANHYDROUS CITRIC ACID D&C YELLOW NO. 10 EDETATE DISODIUM FD&C GREEN NO. 3 FD&C YELLOW NO. 6 GLYCERIN PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE SORBITOL SUCRALOSE

Mfr: OTC
FunFoxMeds box

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Doxylamine succinate 12.5 mg Phenylephrine HCl 10 mg
Inactive Ingredients
Inactive ingredients alcohol anhydrous citric acid D&C yellow #10 edetate disodium FD&C green #3 FD&C yellow #6 flavor glycerin propylene glycol purified water saccharin sodium sodium benzoate sodium chloride sodium citrate sorbitol solution sucralose
Strengths
30 ml 650 mg 20 mg 12.5 mg 10 mg
Quantities
237 ml
Treats Conditions
Uses Temporarily Relieves Common Cold Flu Symptoms Nasal Congestion Sinus Congestion And Pressure Minor Aches And Pains Headache Fever Sore Throat Runny Nose And Sneezing Cough Due To Minor Throat And Bronchial Irritation Cough To Help You Sleep Reduces Swelling Of Nasal Passages Promotes Nasal And Or Sinus Drainage Temporarily Restores Freer Breathing Through The Nose

Identifiers & Packaging

Container Type UNKNOWN
Packaging

Package/Label Principal Display Panel COMPARE TO the Active Ingredients of Vicks® NyQuil® Severe Maximum Strength Severe Cold & Flu Acetaminophen – Pain Reliever/Fever Reducer Dextromethorphan HBr – Cough Suppressant Doxylamine Succinate - Antihistamine Phenylephrine HCl – Nasal Decongestant Nighttime Headache, Fever, Sore Throat, Minor Aches & Pains Nasal/Sinus Congestion & Sinus Pressure Sneezing, Runny Nose Cough 10% ALCOHOL 8 FL OZ (237 mL) Severe Cold & Flu Image 1 Severe Cold & Flu Image 2

Package Descriptions
  • Package/Label Principal Display Panel COMPARE TO the Active Ingredients of Vicks® NyQuil® Severe Maximum Strength Severe Cold & Flu Acetaminophen – Pain Reliever/Fever Reducer Dextromethorphan HBr – Cough Suppressant Doxylamine Succinate - Antihistamine Phenylephrine HCl – Nasal Decongestant Nighttime Headache, Fever, Sore Throat, Minor Aches & Pains Nasal/Sinus Congestion & Sinus Pressure Sneezing, Runny Nose Cough 10% ALCOHOL 8 FL OZ (237 mL) Severe Cold & Flu Image 1 Severe Cold & Flu Image 2

Overview

Uses temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion and pressure • minor aches and pains • headache • fever • sore throat • runny nose and sneezing • cough due to minor throat and bronchial irritation • cough to help you sleep • reduces swelling of nasal passages • promotes nasal and/or sinus drainage • temporarily restores freer breathing through the nose

Indications & Usage

Uses temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion and pressure • minor aches and pains • headache • fever • sore throat • runny nose and sneezing • cough due to minor throat and bronchial irritation • cough to help you sleep • reduces swelling of nasal passages • promotes nasal and/or sinus drainage • temporarily restores freer breathing through the nose

Dosage & Administration

Directions • take only as directed – see Overdose warning • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

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 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.
Purpose

Purpose Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

Do Not Use

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

When Using

When using this product • do not use more than directed • excitability may occur, especially in children • marked drowsiness may occur • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop Use & Ask a Doctor

Stop use and ask a doctor if • you get nervous, dizzy or sleepless • 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.

Keep Out of Reach of Children

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). 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: sodium 44 mg • store at 20-25 ° C (68-77 ° F)

Questions

Questions or comments? 1-800-719-9260


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