Severe Nighttime Cold and Flu Relief
Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl · Tablet, Film Coated · Oral
Active ingredient
Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Doxylamine succinate 12.5 mg Phenylephrine HCI 10 mg
Purpose
Purposes Pain reliever/fever reducer Cough suppressant Antihistamine Nasal Decongestant
Uses
Uses temporarily relieves common cold/flu symptoms: nasal congestion sore throat headache sinus congestion and pressure minor ache and pain runny nose and sneezing cough due to minor throat and bronchial irritation temporarily reduces fever cough to help you sleep swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage
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 everyday 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 is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarges prostate gland 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 a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking 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 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 last more than 3 days redness or swelling is present cough comes back, or occurs with rash or headache that lasts. These could be a signs of a serious conditions. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning : Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical 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. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
Ask a doctor before use
Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarges prostate gland 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 a sodium-restricted diet
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking taking sedatives or tranquilizers taking the blood thinning drug warfarin
When using this product
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 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 last more than 3 days redness or swelling is present cough comes back, or occurs with rash or headache that lasts. These could be a signs of a serious conditions.
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. Overdose warning : Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
Directions
Directions take only as directed - see Overdose warning do not exceed 4 doses per 24 hours measure only with dosing cup provided. Do not use any other dosing device. mL = milliliter keep dosing cup with product adults and children 12 years and over: 30 mL every 4 hours children under 12 years of age: do not use When using Daytime or Nighttime products, carefully read each label to ensure correct dosing.
Other information
Other information each 30 mL contains ; sodium 64 mg store between 20-25ºC (68-77ºF). Do not refrigerate
Inactive ingredients
Inactive ingredients anhydrous citric acid. FD&C blue1, FD&C red 40, Flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum
Questions?
Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Label text from the FDA structured product label by Family Dollar (FAMILY WELLNESS) (revised Nov 24, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acetaminophen in 2 products
- Dextromethorphan Hydrobromide in 2 products
- Doxylamine Succinate in 2 products
- Phenylephrine Hydrochloride in 2 products
Severe Nighttime Cold and Flu Relief NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 55319-641 | Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 20 mg/30mL; Doxylamine Succinate 12.5 mg/30mL; Phenylephrine… Liquid | Family Dollar (FAMILY WELLNESS) | OTC MONOGRAPH DRUG |
| 11822-0677 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Doxylamine Succinate 6.25 mg/1; Phenylephrine… Tablet, Film Coated | Rite Aid Corporation | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Severe Nighttime Cold and Flu Relief used for?
Uses temporarily relieves common cold/flu symptoms: nasal congestion sore throat headache sinus congestion and pressure minor ache and pain runny nose and sneezing cough due to minor throat and bronchial irritation temporarily reduces fever cough to help you sleep swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage
Who makes Severe Nighttime Cold and Flu Relief?
Severe Nighttime Cold and Flu Relief is listed by 2 labelers in the FDA NDC directory, including Family Dollar (FAMILY WELLNESS), Rite Aid Corporation.