Drugplain

night time 650 mg/30mL

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate · SOLUTION · H E B

9 Recalls on RecordCurrently in Shortage
Plain English

Night Time is an over-the-counter liquid medicine that combines acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), and doxylamine succinate (a sleep aid) to help relieve nighttime cold and flu symptoms including cough, aches, fever, and sleeplessness. It is taken by mouth and is intended for use at night when you need symptom relief and rest.

Key Facts

Brand Name
night time
Generic Name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
NDC Code (Product)
37808-459
Manufacturer
H E B
Strength
650 mg/30mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
02/04/2012

Recall History

9 Recalls on Record
Class II07/10/2019

LNK International, Inc.

Microbial contamination of non-sterile product

TerminatedVoluntary: Firm initiated
Class I04/15/2015

Reckitt Benckiser LLC

Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.

TerminatedVoluntary: Firm initiated
Class II06/29/2022

Mckesson Medical-Surgical Inc. Corporate Office

CGMP Deviations: products were stored outside the drug label specifications.

TerminatedVoluntary: Firm initiated
Class III04/15/2014

P&L Developments, LLC

Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution.

TerminatedVoluntary: Firm initiated
Class II05/03/2023

Denison Pharmaceuticals, LLC

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

OngoingVoluntary: Firm initiated
Class I04/15/2015

Reckitt Benckiser LLC

Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.

TerminatedVoluntary: Firm initiated
Class I04/15/2015

Reckitt Benckiser LLC

Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.

TerminatedVoluntary: Firm initiated
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated
Class II06/23/2023

Kramer Laboratories, Inc.

CGMP Deviations: use of non-food grade lubricant in mixing vessel.

TerminatedVoluntary: Firm initiated

Frequently Asked Questions

What is night time used for?

Night Time is an over-the-counter liquid medicine that combines acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), and doxylamine succinate (a sleep aid) to help relieve nighttime cold and flu symptoms including cough, aches, fever, and sleeplessness. It is taken by mouth and is intended for use at night when you need symptom relief and rest.

Is night time a controlled substance?

night time is not classified as a controlled substance by the DEA.

What is the generic name for night time?

The generic name for night time is Acetaminophen, Dextromethorphan HBr, Doxylamine succinate. There are 12 other brand versions of Acetaminophen, Dextromethorphan HBr, Doxylamine succinate.

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

The NDC (National Drug Code) for night time 650 mg/30mL is 37808-459, listed by H E B.