Nighttime Severe Cold and Flu Maximum Strength mini softgels
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl · Capsule, Liquid Filled · Oral
Active ingredient
Active ingredient (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl - 5 mg
Purpose
Purpose Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant
Uses
Uses temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache cough nasal and sinus congestion sore throat temporarily reduces fever runny nose, sneezing
Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: skin reddening blisters rash hives facial swelling asthma (wheezing) shock. If a skin or general allergic 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 in children or to sedate children.
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 if you have ever had an allergic reaction to this product or any of its ingredients in children under 12 years of age
Ask a doctor before use
Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes cough with excessive phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers
When using this product
When using this product do not exceed recommended dosage may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children
Stop use and ask a doctor
Stop use and ask a doctor if pain, cough, or nasal congestion 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 nervousness, dizziness, or sleeplessness occurs
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 (1-800-222-1222) right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.
Directions
Directions do not take more than the recommended dose adults & children 12 yrs & over: take 2 softgels with water every 4 hrs. Do not exceed 10 softgels in 24 hours or as directed by a doctor children under 12 yrs: do not use
Inactive ingredients
Inactive ingredients anhydrous citric acid, FD&C Blue No. 1, FD&C Yellow No. 10, gelatin, glycerin, isopropyl alcohol, mica, N-butyl alcohol, polyethylene glycol-400, propylene glycol, povidone (PVP K30), purified water, shellac, sorbitol solution, titanium dioxide
Questions?
Questions or comments? 1-800-373-6981
Label text from the FDA structured product label by Shield Pharmaceuticals Corp (revised Aug 26, 2026). 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
Nighttime Severe Cold and Flu Maximum Strength mini softgels NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 83059-0074 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Doxylamine Succinate 6.25 mg/1; Phenylephrine… Capsule, Liquid Filled | Shield Pharmaceuticals Corp | OTC MONOGRAPH DRUG |
| 83059-0095 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Doxylamine Succinate 6.25 mg/1; Phenylephrine… Capsule, Liquid Filled | Shield Pharmaceuticals Corp | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Nighttime Severe Cold and Flu Maximum Strength mini softgels used for?
Uses temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache cough nasal and sinus congestion sore throat temporarily reduces fever runny nose, sneezing
Who makes Nighttime Severe Cold and Flu Maximum Strength mini softgels?
Nighttime Severe Cold and Flu Maximum Strength mini softgels is listed by 1 labeler in the FDA NDC directory, including Shield Pharmaceuticals Corp.