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Night Time Cold and Flu

Dosage form
CAPSULE, LIQUID FILLED
Labeler
Retail Business Services, LLC
Label updated
2024-11-21
Retrieved
2026-09-07
Active ingredients
ACETAMINOPHEN · DEXTROMETHORPHAN HYDROBROMIDE · DOXYLAMINE SUCCINATE
View original label and images on DailyMed ↗
Label information

Drug Facts

Active ingredient (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses
  • temporarily relieves these common cold and flu symptoms:
  • cough
  • nasal congestion
  • minor aches and pains
  • sore throat
  • headache
  • runny nose
  • sneezing
  • temporarily reduces fever
  • controls cough to help you get to sleep
Warnings

Liver warningThis product contains acetaminophen. Severe liver damage may occur if you take
• more than 4 doses in 24 hrs, 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
  • diabetes
  • high blood pressure
  • thyroid disease
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • breathing problems such as emphysema or chronic bronchitis
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

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
  • 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.

Label information

If pregnant or breast-feeding,ask a health professional before use.

Label information

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 right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
  • do not take more than directed (see Overdose warning)
  • do not take more than 12 softgels in any 24-hour period
  • adults and children 12 years of age and older: take 2 softgels every 4 hours
  • children under 12 years of age: do not use
Other information
  • store between 15-30°C (59-86°F)
  • avoid excessive heat
Inactive ingredient

D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, and white edible ink

Questions or Comments?

Call toll free: 1-866-322-2439

PRINCIPAL DISPLAY PANEL

CareOne Nighttime Cold & Flu 16ct

compare to Mucinex Fast-Max Night Time Cold & Flu active ingredients

NDC 72476-998-14

[Image in the official label — see DailyMed source]

[Image in the official label — see DailyMed source]

DailyMed Set ID: fc8c70d6-6be5-4f12-84b0-125fc82149ec · Version 2
NDC: 72476-998