Nighttime Cold and Flu 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 15 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 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 8 Softgels 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 n 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
• 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 FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 10, gelatin, glycerin, isopropyl alcohol, MCT Oil, polyethylene glycol-400, propylene glycol, povidone, purified water, silver sheen, sorbitol solution
Questions?
Questions or comments? 1-800-373-6981 (toll-free)
Label text from the FDA structured product label by Shield Pharmaceuticals Corp (revised Feb 3, 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
- Phenylephrine Hydrochloride in 1 product
Nighttime Cold and Flu Mini Softgels NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 83059-0129 | Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 15 mg/1; Doxylamine Succinate 6.25 mg/1; Phenylephrine… Capsule, Liquid Filled | Shield Pharmaceuticals Corp | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Nighttime Cold and Flu Mini Softgels 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 Mini Softgels?
Nighttime Cold and Flu Mini Softgels is listed by 1 labeler in the FDA NDC directory, including Shield Pharmaceuticals Corp.