Theraflu Severe Cold Relief ACETAMINOPHEN DEXTROMETHORPHAN HBR DIPHENPHYDRAMINE HCL GUAIFENESIN HALEON US HOLDINGS LLC FDA Approved Uses (Daytime) • temporarily relieves these symptoms due to a cold: • minor aches and pains • minor sore throat pain • headache • cough due to minor throat and bronchial irritation • temporarily reduces fever • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive Uses (Nighttime) • temporarily relieves these symptoms due to a cold: • minor aches and pains • minor sore throat pain • headache • 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

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each 30 mL) (Daytime) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg Active ingredients (in each 30 mL) (Nighttime) Acetaminophen 650 mg Diphenhydramine HCl 25 mg
Inactive Ingredients
Inactive ingredients (Daytime) acesulfame potassium anhydrous citric acid edetate disodium FD&C blue no. 1 FD&C red no. 40 glycerin maltitol solution natural and artificial flavors propylene glycol purified water sodium benzoate sodium citrate Inactive ingredients (Nighttime) acesulfame potassium anhydrous citric acid edetate disodium FD&C blue no. 1 FD&C red no. 40 glycerin maltitol solution natural and artificial flavors propylene glycol purified water sodium benzoate sodium citrate
Strengths
30 ml 650 mg 20 mg 400 mg 25 mg
Quantities
5 ml 491 ml
Treats Conditions
Uses Daytime Temporarily Relieves These Symptoms Due To A Cold Minor Aches And Pains Minor Sore Throat Pain Headache Cough Due To Minor Throat And Bronchial Irritation Temporarily Reduces Fever Helps Loosen Phlegm Mucus And Thin Bronchial Secretions To Rid The Bronchial Passageways Of Bothersome Mucus And Make Coughs More Productive Uses Nighttime Temporarily Relieves These Symptoms Due To A Cold Minor Aches And Pains Minor Sore Throat Pain Headache 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
Pill Appearance
Color: red

Identifiers & Packaging

Container Type BOTTLE
Packaging

Principal Display Panel (Day/Night Combination) MULTI-SYMPTOM COLD RELIEF NEW FORMULA VALUE PACK DAYTIME FORMULA SEVERE COLD RELIEF MULTI-SYMPTOM COLD RELIEF NEW FORMULA THERAFLU SEVERE COLD RELIEF + CHEST CONGESTION ACETAMINOPHEN Pain Reliever/Fever Reducer Dextromethorphan HBr Cough suppressant Guaifenesin / Expectorant DAYTIME FORMULA Powerful formula that relieves: / Chest congestion / Thins and loosens mucus / Head and body ache / Fever / Cough / Sore throat pain 8.3 FL OZ (245.5 mL) Berry Flavor SEVERE COLD RELIEF HELPS YOU REST* MULTI-SYMPTOM COLD RELIEF NEW FORMULA THERAFLU SEVERE COLD RELIEF NIGHTTIME Acetaminophen Pain Reliever/Fever Reducer Diphenhydramine HCl Antihistamine/Cough Suppressant HELPS YOU REST* Powerful formula that relieves: / Cough / Sore throat pain / Head and body ache / Fever / Runny nose / Sneezing 8.3 FL OZ (245.5 mL) Berry Flavor 2-8.3 FL OZ (245.5 mL) BOTTLES TOTAL 16.6 FL OZ (491 mL) USE ONLY AS DIRECTED Theraflu-SCR-DayNight-ComboPack

Package Descriptions
  • Principal Display Panel (Day/Night Combination) MULTI-SYMPTOM COLD RELIEF NEW FORMULA VALUE PACK DAYTIME FORMULA SEVERE COLD RELIEF MULTI-SYMPTOM COLD RELIEF NEW FORMULA THERAFLU SEVERE COLD RELIEF + CHEST CONGESTION ACETAMINOPHEN Pain Reliever/Fever Reducer Dextromethorphan HBr Cough suppressant Guaifenesin / Expectorant DAYTIME FORMULA Powerful formula that relieves: / Chest congestion / Thins and loosens mucus / Head and body ache / Fever / Cough / Sore throat pain 8.3 FL OZ (245.5 mL) Berry Flavor SEVERE COLD RELIEF HELPS YOU REST* MULTI-SYMPTOM COLD RELIEF NEW FORMULA THERAFLU SEVERE COLD RELIEF NIGHTTIME Acetaminophen Pain Reliever/Fever Reducer Diphenhydramine HCl Antihistamine/Cough Suppressant HELPS YOU REST* Powerful formula that relieves: / Cough / Sore throat pain / Head and body ache / Fever / Runny nose / Sneezing 8.3 FL OZ (245.5 mL) Berry Flavor 2-8.3 FL OZ (245.5 mL) BOTTLES TOTAL 16.6 FL OZ (491 mL) USE ONLY AS DIRECTED Theraflu-SCR-DayNight-ComboPack

Overview

Uses (Daytime) • temporarily relieves these symptoms due to a cold: • minor aches and pains • minor sore throat pain • headache • cough due to minor throat and bronchial irritation • temporarily reduces fever • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive Uses (Nighttime) • temporarily relieves these symptoms due to a cold: • minor aches and pains • minor sore throat pain • headache • 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 (Daytime) • temporarily relieves these symptoms due to a cold: • minor aches and pains • minor sore throat pain • headache • cough due to minor throat and bronchial irritation • temporarily reduces fever • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive Uses (Nighttime) • temporarily relieves these symptoms due to a cold: • minor aches and pains • minor sore throat pain • headache • 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 (Daytime) • 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) in 24 hours unless directed by a doctor Age Dose adults and children 12 years of age and over 30 mL children under 12 years of age do not use Directions (Nighttime) • 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) in 24 hours unless directed by a doctor Age Dose adults and children 12 years of age and over 30 mL children under 12 years of age do not use

Warnings & Precautions
Warnings (Daytime) 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 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. • 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 • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin Stop use and ask a doctor if • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • pain or cough 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. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Warnings (Nighttime) 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 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. Ask a doctor before use if you have • liver disease • glaucoma • 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 Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin When using this product • 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 and ask a doctor if • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • pain or cough 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. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Purpose

Purposes (Daytime) Pain reliever/Fever reducer Cough suppressant Expectorant Purposes (Nighttime) Pain reliever/Fever reducer Antihistamine/Cough suppressant

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. • 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. 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 • 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 • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • pain or cough 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. Stop use and ask a doctor if • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • pain or cough 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.

Keep Out of Reach of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Questions

Questions or comments? (Daytime) 1-855-328-5259 Questions or comments? (Nighttime) 1-855-328-5259


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