Severe Congestion and Cough, Cold and Flu
Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl, Triprolidine HCl · Kit
Active ingredient
Active ingredients (in each 20 mL) Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg Active ingredients (in each 20 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Triprolidine HCl 2.5 mg
Purpose
Purpose Cough suppressant Expectorant Nasal decongestant Purpose Pain reliever/fever reducer Cough suppressant Antihistamine
Uses
Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep nasal congestion due to a cold Uses temporarily relieves these common cold and flu symptoms: runny nose headache cough sneezing sore throat minor aches and pains itching of the nose or throat itchy, watery eyes due to hay fever temporarily reduces fever controls cough to help you get to sleep
Warnings
Warnings Do not use 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 difficulty in urination due to enlargement of the prostate gland thyroid disease persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema high blood pressure heart disease diabetes cough that occurs with too much phlegm (mucus) When using this product do not exceed recommended dosage. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not get better within 7 days or occur with fever cough persists more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. 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. 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: rash blisters skin reddening 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 cough that occurs with too much phlegm (mucus) difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product excitability may occur, especially in children marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days new symptoms occur 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 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 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 difficulty in urination due to enlargement of the prostate gland thyroid disease persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema high blood pressure heart disease diabetes cough that occurs with too much phlegm (mucus) Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin
When using this product
When using this product do not exceed recommended dosage. When using this product excitability may occur, especially in children marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery
Stop use and ask a doctor
Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not get better within 7 days or occur with fever cough persists more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition. Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days new symptoms occur 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. 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. 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 do not take more than 6 doses in any 24-hour period mL = milliliter only use the dose cup provided adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours children under 12 years: do not use Directions do not take more than directed do not take more than 4 doses in any 24-hour period mL = milliliter only use the dose cup provided adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours children under 12 years: do not use
Other information
Other information each 20 mL contains: sodium 9 mg use by expiration date on package store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) Other information store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package
Inactive ingredients
Inactive ingredients anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose, xanthan gum Inactive ingredients anhydrous citric acid, FD&C blue #1, FD&C red #40, FD&C yellow #6, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum
Questions?
Questions or comments? 1-800-426-9391
Label text from the FDA structured product label by Walgreen Company (revised Dec 16, 2025). Long sections are shortened; the complete label is on DailyMed.
Severe Congestion and Cough, Cold and Flu NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0363-4063 | Kit | Walgreen Company | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Severe Congestion and Cough, Cold and Flu used for?
Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep nasal congestion due to a cold Uses temporarily…
Who makes Severe Congestion and Cough, Cold and Flu?
Severe Congestion and Cough, Cold and Flu is listed by 1 labeler in the FDA NDC directory, including Walgreen Company.