Active Ingredients And Purpose
Active ingredients (in each caplet)
Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg
Purpose
Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant
Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg
Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant
temporarily relieves these common cold and flu symptoms: sore throat cough nasal congestion headache minor aches and pains helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever
Liver warning : This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg) in 24 hours. 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 for followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
do not take more than directed adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
D&C Yellow#10, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone*, pregelatinized starch, talc, titanium dioxide *may contain this ingredient
1-888-333-9792
DAYTIME NON-DROWSY SEVERE COLD MULTI-SYMPTOM • Acetaminophen - Pain Reliever / Fever Reducer • Dextromethorphan HBr - Cough Suppressant • Guaifenesin- Expectorant • Phenylephrine HCl - Nasal Decongestant 12 caplets
| Name | UNII | Kind |
|---|---|---|
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POLYVINYL ALCOHOL, UNSPECIFIED | 532B59J990 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| POVIDONE | FZ989GH94E | IACT |
Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg
Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant
temporarily relieves these common cold and flu symptoms: sore throat cough nasal congestion headache minor aches and pains helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever
Liver warning : This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg) in 24 hours. 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 for followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
do not take more than directed adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
D&C Yellow#10, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone*, pregelatinized starch, talc, titanium dioxide *may contain this ingredient
1-888-333-9792
DAYTIME NON-DROWSY SEVERE COLD MULTI-SYMPTOM • Acetaminophen - Pain Reliever / Fever Reducer • Dextromethorphan HBr - Cough Suppressant • Guaifenesin- Expectorant • Phenylephrine HCl - Nasal Decongestant 12 caplets
Official SPL XML cached by FDA.report · DailyMed PDF
| Folder | File | Date |
|---|---|---|
| otc | 2929990b-33c1-b1a9-e063-6394a90a7302.xml | 2024-12-15 |
| otc | 0c02da0c-d1b3-a118-e063-6294a90adbd8.xml | 2023-12-09 |
| otc | ee8ee0ab-fc76-dc57-e053-2a95a90adf2d.xml | 2022-11-30 |
| otc | c68d310c-f625-9045-e053-2a95a90ab100.xml | 2021-07-15 |
| otc | c5ee92e1-e3a7-f7e9-e053-2995a90ae991.xml | 2021-06-30 |
| otc | RR.jpg | 2021-06-30 |