NiteTime SEVERE Cold and Flu Relief SOFTGELS
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride · Capsule, Liquid Filled · Oral
Active ingredient
Active ingredients (in each softgel) Acetaminophen 325 mg Dextramethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg
Purpose
Purposes Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant
Uses
Uses
• temporarily relieves common cold/flu symptoms:
• nasal congestion
• sinus congestion & pressure
• cough due to minor throat & bronchial irritation
• cough to help you sleep
• minor aches & pains
• headache
• fever
• sore throat
• runny nose & sneezing
• reduces 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 8 softgels 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 an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have
• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• trouble urinating due to enlarged 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 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
• you get nervous, dizzy, or sleepless
• pain, nasal congestion, 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.
Keep out of reach of children
Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Directions
• take only as directed
• do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over 2 softgels with water every 4 hours children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
Other information
Other information
• store at controlled room temperature between 20-25°C (68-77°F)
• protect from light, heat, and moisture
Inactive ingredients
Inactive ingredients D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide
Questions?
Questions or comments? Call 1 -888-423-0139
Label text from the FDA structured product label by Topco Associates LLC (revised Dec 10, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acetaminophen in 1 product
- Dextromethorphan Hydrobromide in 1 product
- Doxylamine Succinate in 1 product
- Phenylephrine Hydrochloride in 1 product
NiteTime SEVERE Cold and Flu Relief SOFTGELS NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 76162-637 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Doxylamine Succinate 6.25 mg/1; Phenylephrine… Capsule, Liquid Filled | Topco Associates LLC | OTC MONOGRAPH DRUG |
Frequently asked questions
What is NiteTime SEVERE Cold and Flu Relief SOFTGELS used for?
Uses • temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion & pressure • cough due to minor throat & bronchial irritation • cough to help you sleep • minor aches & pains • headache • fever • sore throat • runny nose & sneezing • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage
Who makes NiteTime SEVERE Cold and Flu Relief SOFTGELS?
NiteTime SEVERE Cold and Flu Relief SOFTGELS is listed by 1 labeler in the FDA NDC directory, including Topco Associates LLC.