Basic Care Severe Cold and Flu ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHRINE HYDROCHLORIDE AMAZON.COM SERVICES LLC FDA Approved Uses • temporarily relieves these symptoms due to a cold: • minor aches and pains • minor sore throat pain • headache • nasal and sinus congestion • cough due to minor throat and bronchial irritation • temporarily reduces fever
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each packet) Acetaminophen 500 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg
Inactive Ingredients
Inactive ingredients acesulfame potassium anhydrous citric acid aspartame colloidal silicon dioxide D&C yellow #10 FD&C blue #1 FD&C red #40 flavors maltodextrin pregelatinized starch sodium citrate sucrose tribasic calcium phosphate
Strengths
500 mg 20 mg 10 mg
Quantities
6 pack
Treats Conditions
Uses Temporarily Relieves These Symptoms Due To A Cold Minor Aches And Pains Minor Sore Throat Pain Headache Nasal And Sinus Congestion Cough Due To Minor Throat And Bronchial Irritation Temporarily Reduces Fever

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
362O9ITL9D 9D2RTI9KYH 04JA59TNSJ
Packaging

Package/Label Principal Display Panel Daytime Compare to Theraflu® Severe Cold active ingredients Multi-Symptom Severe Cold & Flu Acetaminophen – Pain Reliever/Fever Reducer Dextromethorphan HBr – Cough Suppressant Phenylephrine HCl – Nasal Decongestant - Nasal & Sinus Congestion - Cough - Body Ache - Sore Throat Pain - Headache - Fever 6 PACKETS Green Tea & Honey Lemon Flavors Severe Cold & Flu Carton

Package Descriptions
  • Package/Label Principal Display Panel Daytime Compare to Theraflu® Severe Cold active ingredients Multi-Symptom Severe Cold & Flu Acetaminophen – Pain Reliever/Fever Reducer Dextromethorphan HBr – Cough Suppressant Phenylephrine HCl – Nasal Decongestant - Nasal & Sinus Congestion - Cough - Body Ache - Sore Throat Pain - Headache - Fever 6 PACKETS Green Tea & Honey Lemon Flavors Severe Cold & Flu Carton

Overview

Uses • temporarily relieves these symptoms due to a cold: • minor aches and pains • minor sore throat pain • headache • nasal and sinus congestion • 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 • cough due to minor throat and bronchial irritation • temporarily reduces fever

Dosage & Administration

Directions • do not use more than directed (see overdose warning) • take every 4 hours, while symptoms persist. Do not take more than 6 packets in 24 hours unless directed by a doctor. Age Dose adults and children 12 years of age and over one packet children under 12 years of age do not use • dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes. • if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.

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. Do not use • in a child under 12 years of age • if you have ever had an allergic reaction to this product or any of its ingredients • 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. 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 • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema • a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Purpose

Purposes Pain reliever/fever reducer Cough suppressant Nasal decongestant

Do Not Use

Do not use • in a child under 12 years of age • if you have ever had an allergic reaction to this product or any of its ingredients • 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.

When Using

When using this product do not exceed recommended dosage 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 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.

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 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). Prompt 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 packet contains: potassium 10 mg and sodium 25 mg • phenylketonurics: contains phenylalanine 22 mg per packet • store at 20-25 ° C (68-77 ° F). Protect product from heat and moisture.

Questions

Questions or comments? 1-800-719-9260


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