Nighttime Cold and Flu Multi Symptom Relief
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate · Capsule, Liquid Filled · Oral
Active ingredient
Active ingredient (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg
Purpose
Purpose Pain reliever/fever reducer Cough suppressant Antihistamine
Uses
Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose & sneezing
Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 4000 mg in 24 hrs, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily 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
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 liver disease glaucoma 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 trouble urinating due to enlarged 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 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, & tranquilizers may increase drowsiness
Stop use and ask a doctor
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.
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
• take only as directed
• do not exceed 8 softgels per 24 hrs
• adults & children 12 yrs & over: 2 Softgels with water every 6 hrs
• children 4 to under 12 yrs: ask a doctor
• children under 4 yrs: do not use
Inactive ingredients
Inactive ingredients anhydrous citric acid, FD&C Blue No. 1, D&C Yellow No. 10, gelatin, glycerin, isopropyl alcohol, N-butyl alcohol, polyethylene glycol-400, povidone (PVP K30), propylene glycol, 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 Sep 2, 2026). 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
Nighttime Cold and Flu Multi Symptom Relief NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 83059-0177 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 15 mg/1; Doxylamine Succinate 6.25 mg/1 Capsule, Liquid Filled | Shield Pharmaceuticals Corp | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Nighttime Cold and Flu Multi Symptom Relief used for?
Uses temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose & sneezing
Who makes Nighttime Cold and Flu Multi Symptom Relief?
Nighttime Cold and Flu Multi Symptom Relief is listed by 1 labeler in the FDA NDC directory, including Shield Pharmaceuticals Corp.