Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack
Dextromethorphan HBr, Guaifenesin, Acetaminophen, Doxylamine Succinate · Kit
Active ingredient
Active ingredients (in each 20 mL) Dextromethorphan HBr 20 mg Guaifenesin 400 mg Active ingredients (in each 20 mL) Acetaminophen 650 mg Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg
Purpose
Purposes Cough suppressant Expectorant Purposes 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 Uses temporarily relieves these common cold and flu symptoms: cough due to minor throat and bronchial irritation minor aches and pains sore throat headache runny nose sneezing 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 persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) When using this product do not use more than directed Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, 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 (1-800-222-1222). Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours, which is the maximum daily amount for this product 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 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 or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema glaucoma trouble urinating due to enlarge prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness 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 redness or swelling is present new symptoms occur 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 (1-800-222-1222). 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 MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use
Ask a doctor before use if you have 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 before use if you have liver disease cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema glaucoma trouble urinating due to enlarge prostate gland
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 use more than directed When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness
Stop use and ask a doctor
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. 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 redness or swelling is present new symptoms occur 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 (1-800-222-1222). Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
Directions SHAKE WELL BEFORE EACH USE do not take more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours children under 12 years of age: do not use Directions SHAKE WELL BEFORE EACH USE only take as directed only use the dose cup provided do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 20 mL every 6 hours children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
Other information
Other information store between 20-25ºC (68-77ºF) do not refrigerate Other information store between 20-25°C (68-77°F) do not refrigerate
Inactive ingredients
Inactive ingredients organic agave syrup, organic blueberry flavor, natural flavors, purified water Inactive ingredients organic agave syrup, organic blueberry flavor, organic chamomile extract, natural flavors, purified water
Questions?
Questions? 1-855-436-3921 You may also report side effects to this phone number. Questions? 1-855-436-3921 You may also report side effects to this phone number.
Label text from the FDA structured product label by Genexa Inc. (revised Jul 2, 2025). Long sections are shortened; the complete label is on DailyMed.
Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 69676-0079 | Kit | Genexa Inc. | OTC MONOGRAPH DRUG |
Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack recalls
- D-0033-2025 Nov 13, 2024 · Class III · Ongoing
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles. - D-0034-2025 Nov 13, 2024 · Class III · Ongoing
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Frequently asked questions
What is Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack 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 Uses temporarily relieves these common cold and flu…
Who makes Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack?
Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack is listed by 1 labeler in the FDA NDC directory, including Genexa Inc..
Has Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack been recalled?
The FDA enforcement database lists 2 recalls for Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack, most recently D-0033-2025 (class iii): Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.