Drugplain

nighttime 650 mg/30mL

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate · SOLUTION · Publix Super Markets Inc

10 Recalls on RecordCurrently in Shortage
Plain English

nighttime is a solution containing acetaminophen, dextromethorphan hbr, doxylamine succinate at 650 mg/30mL, taken oral. Manufactured by Publix Super Markets Inc.

Key Facts

Brand Name
nighttime
Generic Name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
NDC Code (Product)
56062-459
Manufacturer
Publix Super Markets Inc
Strength
650 mg/30mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
11/07/2011

Recall History

10 Recalls on Record
Class II06/18/2013

Novartis Consumer Health

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

TerminatedVoluntary: Firm initiated
Class II03/04/2025

Chattem Inc

CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.

OngoingVoluntary: Firm initiated
Class II06/18/2013

Novartis Consumer Health

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

TerminatedVoluntary: Firm initiated
Class III08/04/2022

LNK International, Inc.

Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.

TerminatedVoluntary: Firm initiated
Class II06/18/2013

Novartis Consumer Health

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

TerminatedVoluntary: Firm initiated
Class II06/18/2013

Novartis Consumer Health

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

TerminatedVoluntary: Firm initiated
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class II08/04/2020

Eosera, Inc.

cGMP Deviations.

TerminatedVoluntary: Firm initiated
Class II11/08/2012

Procter & Gamble Co

Labeling Illegible: Portions of the product labeling in the area of the dosing directions, the warnings & other information sections is obscured.

TerminatedVoluntary: Firm initiated
Class III08/06/2013

Novartis Consumer Health

Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

off label use23,623 reports
fatigue22,137 reports
drug ineffective20,447 reports
pain19,350 reports
nausea19,267 reports
headache18,171 reports
toxicity to various agents17,467 reports
dyspnoea15,908 reports
arthralgia15,168 reports
pyrexia15,127 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Indications & Usage Temporarily relieves coughs due to minor throat and bronchial irritation as may occur with a cold. Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. Soothes the throat.

Dosage & Administration

Dosage & Administration Directions Shake well before each use. Adults & children 12 years of age and older: Take 2 teaspoons (tsp) (10mL) 1/2 hour before bedtime. Dose may be repeated if necessary. Children under 12 years of age: Consult a doctor.

Warnings

Warnings Sore Throat Warning: if sore throat is severe, persists more than 2 days, is accompanied or followed by a fever, headache, rash, nausea, or vomiting, c onsult a doctor promptly.

Frequently Asked Questions

What is nighttime used for?

nighttime contains Acetaminophen, Dextromethorphan HBr, Doxylamine succinate. It is a solution taken oral. Consult your doctor for specific uses.

Is nighttime a controlled substance?

nighttime is not classified as a controlled substance by the DEA.

What is the generic name for nighttime?

The generic name for nighttime is Acetaminophen, Dextromethorphan HBr, Doxylamine succinate. There are 11 other brand versions of Acetaminophen, Dextromethorphan HBr, Doxylamine succinate.

What is the NDC code for nighttime 650 mg/30mL?

The NDC (National Drug Code) for nighttime 650 mg/30mL is 56062-459, listed by Publix Super Markets Inc.