CVS NightTime Cold 650 mg/30mL

acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride · SOLUTION · CVS PHARMACY

No Recall HistoryCurrently in Shortage

Plain English

CVS NightTime Cold is a solution containing acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride at 650 mg/30mL, taken oral. Manufactured by CVS PHARMACY.

Key Facts

Brand Name: CVS NightTime Cold
Generic Name: acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride
NDC Code (Product): 51316-641
Manufacturer: CVS PHARMACY
Strength: 650 mg/30mL
Dosage Form: SOLUTION
Route: ORAL
Marketing Status
Application #: M010
Marketing Start: 01/09/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

contusion1 reports

dehydration1 reports

drug toxicity1 reports

hepatic necrosis1 reports

hepatic steatosis1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

Directions take only as directed only use the dose cup provided do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Warnings

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses 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 dise…

Frequently Asked Questions

What is CVS NightTime Cold used for?

CVS NightTime Cold contains acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride. It is a solution taken oral. Consult your doctor for specific uses.

Is CVS NightTime Cold a controlled substance?

CVS NightTime Cold is not classified as a controlled substance by the DEA.

What is the generic name for CVS NightTime Cold?

The generic name for CVS NightTime Cold is acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride. There are 7 other brand versions of acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride.

What is the NDC code for CVS NightTime Cold 650 mg/30mL?

The NDC (National Drug Code) for CVS NightTime Cold 650 mg/30mL is 51316-641, listed by CVS PHARMACY.

Product NDC

51316-641

Package NDC

51316-641-12

Other Acetaminophen, Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)