Drugplain

day time 325 mg/1

Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride · CAPSULE, LIQUID FILLED · H E B

5 Recalls on RecordCurrently in Shortage
Plain English

Day Time is an over-the-counter cold and flu medicine in capsule form that combines acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), and phenylephrine (a nasal decongestant). It is taken by mouth to help relieve symptoms like cough, congestion, aches, and fever.

Key Facts

Brand Name
day time
Generic Name
Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
NDC Code (Product)
37808-994
Manufacturer
H E B
Strength
325 mg/1
Dosage Form
CAPSULE, LIQUID FILLED
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
07/27/2011

Recall History

5 Recalls on Record
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 III04/14/2014

P&L Developments, LLC

Subpotent Drug: Phenylephrine component is subpotent.

TerminatedVoluntary: Firm initiated
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective9,255 reports
pain8,734 reports
fatigue8,579 reports
alopecia7,346 reports
abdominal discomfort7,226 reports
rheumatoid arthritis7,223 reports
systemic lupus erythematosus6,943 reports
pemphigus6,826 reports
off label use6,421 reports
rash6,389 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever

Dosage & Administration

Directions take only as directed only use dose cup provided do not take more than 4 doses per 24 hours Age Dose adults and children 12 years and over 30 mL every 4 hours children 4 to under 12 years ask a doctor children under 4 years do not use

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4 doses (30 mL each) of acetaminophen in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks everyday while using this product Allery 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 non-prescription). 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 two 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

Frequently Asked Questions

What is day time used for?

Day Time is an over-the-counter cold and flu medicine in capsule form that combines acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), and phenylephrine (a nasal decongestant). It is taken by mouth to help relieve symptoms like cough, congestion, aches, and fever.

Is day time a controlled substance?

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

What is the generic name for day time?

The generic name for day time is Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride. There are 12 other brand versions of Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride.

What is the NDC code for day time 325 mg/1?

The NDC (National Drug Code) for day time 325 mg/1 is 37808-994, listed by H E B.