Active Ingredients And Purpose
Active ingredients (in each 30 mL)
Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg
Purposes
Pain reliever/fever reducer Cough suppressant Nasal decongestant
Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg
Pain reliever/fever reducer Cough suppressant Nasal decongestant
• 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
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 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
acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate
1-800-452-0051
NDC 0067-8127-08 THERAFLU ExpressMax DAYTIME SEVERE COLD & COUGH BERRY FLAVOR ACETAMINOPHEN PAIN RELIEVER/FEVER REDUCER DEXTROMETHORPHAN HBr COUGH SUPPRESSANT PHENYLEPHRINE HCl NASAL DECONGESTANT • COUGH • NASAL CONGESTION • SORE THORAT PAIN • FEVER • HEADACHE • BODY ACHE 8.3 FL OZ (245.5mL) Alcohol Free * Maximum Strength per 4 hour dose. DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING Distributed by: GSK Consumer Healthcare , Warren, NJ 07059 Trademarks are owned by or licensed to the GSK group of companies. ©2018 GSK group of companies or its licensor. 13271
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MALTITOL | D65DG142WK | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CITRATE, UNSPECIFIED FORM | 1Q73Q2JULR | IACT |
| WATER | 059QF0KO0R | IACT |
Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg
Pain reliever/fever reducer Cough suppressant Nasal decongestant
• 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
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 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
• each 30 mL contains : potassium 35 mg, sodium 17 mg • store at controlled room temperature 20-25°C (68-77°F)
acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate
1-800-452-0051
NDC 0067-8127-08 THERAFLU ExpressMax DAYTIME SEVERE COLD & COUGH BERRY FLAVOR ACETAMINOPHEN PAIN RELIEVER/FEVER REDUCER DEXTROMETHORPHAN HBr COUGH SUPPRESSANT PHENYLEPHRINE HCl NASAL DECONGESTANT • COUGH • NASAL CONGESTION • SORE THORAT PAIN • FEVER • HEADACHE • BODY ACHE 8.3 FL OZ (245.5mL) Alcohol Free * Maximum Strength per 4 hour dose. DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING Distributed by: GSK Consumer Healthcare , Warren, NJ 07059 Trademarks are owned by or licensed to the GSK group of companies. ©2018 GSK group of companies or its licensor. 13271
Official SPL XML cached by FDA.report · DailyMed PDF
| Folder | File | Date |
|---|---|---|
| otc | 5239b4c6-3ff8-4309-88c1-800335104e40.xml | 2024-02-14 |
| otc | 13411_Theraflu ExpressMAX DT SCC_8.3 OZ.JPG.jpg.jpg.jpg | 2022-04-28 |
| otc | 83aacea7-68a1-494d-b36c-6d72a1e61584.xml | 2022-04-28 |
| otc | 13411_Theraflu ExpressMAX DT SCC_8.3 OZ.JPG.jpg.jpg | 2020-12-16 |
| otc | 1c91de77-8746-47f3-80fe-67701ab4c90a.xml | 2020-12-16 |
| otc | 13411_Theraflu ExpressMAX DT SCC_8.3 OZ.JPG.jpg | 2019-04-04 |
| otc | f7c9686f-ac66-4d41-9b12-cff79e0cd353.xml | 2019-04-04 |