Severe Cold and Flu
acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl · Solution · Oral
Active ingredient
Active ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg
Purpose
Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant
Uses
Uses 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
Warnings
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 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 diabetes heart disease thyroid disease high blood pressure difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product do not exceed recommended dosage. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present 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.
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.
Ask a doctor before use
Ask a doctor before use if you have liver disease diabetes heart disease thyroid disease high blood pressure difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
When using this product
When using this product do not exceed recommended dosage.
Stop use and ask a doctor
Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
Pregnancy or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.
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.
Directions
Directions 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
Other information
Other information each caplet contains: sodium 3 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Inactive ingredients
Inactive ingredients corn starch, crospovidone, D&C yellow #10 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
Questions?
Questions or comments? 1-800-426-9391
Label text from the FDA structured product label by Cardinal Health 110, LLC. DBA Leader (revised Aug 15, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acetaminophen in 16 products
- Dextromethorphan Hydrobromide in 16 products
- Phenylephrine Hydrochloride in 16 products
- Doxylamine Succinate in 9 products
- Guaifenesin in 7 products
Severe Cold and Flu NDC products (20)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 70000-0525 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Guaifenesin 200 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated | Cardinal Health 110, LLC. DBA Leader | OTC MONOGRAPH DRUG |
| 51316-533 | Acetaminophen 325 mg/15mL; Dextromethorphan Hydrobromide 10 mg/15mL; Doxylamine Succinate 6.25 mg/15mL; Phenylephrine… Solution | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | OTC MONOGRAPH DRUG |
| 51316-530 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Guaifenesin 200 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Film Coated | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | OTC MONOGRAPH DRUG |
| 51316-509 | Kit | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | OTC MONOGRAPH DRUG |
| 51316-293 | Acetaminophen 325 mg/15mL; Dextromethorphan Hydrobromide 10 mg/15mL; Guaifenesin 200 mg/15mL; Phenylephrine… Solution | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | OTC MONOGRAPH DRUG |
| 55910-716 | Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 20 mg/30mL; Doxylamine Succinate 12.5 mg/30mL; Phenylephrine… Liquid | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | OTC MONOGRAPH DRUG |
| 42507-763 | Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 20 mg/30mL; Doxylamine Succinate 12.5 mg/30mL; Phenylephrine… Solution | HyVee Inc | OTC MONOGRAPH DRUG |
| 42507-861 | Acetaminophen 325 mg/15mL; Dextromethorphan Hydrobromide 10 mg/15mL; Doxylamine Succinate 6.25 mg/15mL; Phenylephrine… Solution | HyVee Inc | OTC MONOGRAPH DRUG |
| 42507-603 | Acetaminophen 325 mg/15mL; Dextromethorphan Hydrobromide 10 mg/15mL; Guaifenesin 200 mg/15mL; Phenylephrine… Solution | HyVee Inc | OTC MONOGRAPH DRUG |
| 42507-597 | Kit | HyVee Inc | OTC MONOGRAPH DRUG |
| 42507-511 | Acetaminophen 325 mg/15mL; Dextromethorphan Hydrobromide 10 mg/15mL; Guaifenesin 200 mg/15mL; Phenylephrine… Solution | HyVee Inc | OTC MONOGRAPH DRUG |
| 42507-278 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Guaifenesin 200 mg/1; Phenylephrine Hydrochloride 5 mg/1 Tablet, Coated | HYVEE INC | OTC MONOGRAPH DRUG |
| 42507-020 | Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 20 mg/30mL; Doxylamine Succinate 12.5 mg/30mL; Phenylephrine… Solution | HyVee Inc | OTC MONOGRAPH DRUG |
| 49580-0416 | Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 20 mg/30mL; Doxylamine Succinate 12.5 mg/30mL; Phenylephrine… Liquid | P & L Development, LLC | OTC MONOGRAPH DRUG |
| 49580-4160 | Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 20 mg/30mL; Doxylamine Succinate 12.5 mg/30mL; Phenylephrine… Liquid | P & L Development, LLC | OTC MONOGRAPH DRUG |
| 0363-0603 | Acetaminophen 325 mg/15mL; Dextromethorphan Hydrobromide 10 mg/15mL; Guaifenesin 200 mg/15mL; Phenylephrine… Solution | Walgreen Company | OTC MONOGRAPH DRUG |
| 0363-1597 | Kit | Walgreen Company | OTC MONOGRAPH DRUG |
| 0363-0763 | Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 20 mg/30mL; Doxylamine Succinate 12.5 mg/30mL; Phenylephrine… Solution | Walgreen Company | OTC MONOGRAPH DRUG |
| 0363-0623 | Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 20 mg/30mL; Doxylamine Succinate 12.5 mg/30mL; Phenylephrine… Solution | Walgreen Company | OTC MONOGRAPH DRUG |
| 0363-8995 | Kit | Walgreens | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Severe Cold and Flu used for?
Uses 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
Who makes Severe Cold and Flu?
Severe Cold and Flu is listed by 8 labelers in the FDA NDC directory, including Cardinal Health 110, LLC. DBA Leader, CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, Dolgencorp, Inc. (DOLLAR GENERAL & REXALL), HyVee Inc.