Daytime
FDA Label NDC 33992-0611

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Greenbrier International for the product Daytime (NDC 33992-0611). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, boxed warning section, uses, liver warning, sore throat warning, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

 

 


Distributed by:

Greenbrier International, Inc.

Chesapeake, VA 23320

Boxed Warning Section

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever

Liver Warning

This 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 daily while using this product

Sore Throat Warning

If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Otc - When Using

When using this product, do not use more than directed.

Stop Use And Ask A Doctor If

  • you get nervous, dizzy or sleepless
  • symptoms get worse or last more than 5 days (children) or 7 days (adults)
  • 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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdose Warning

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

  • take only as directed - see Overdose Warning
  • do not exceed 4 doses per 24 hrs
  • adults & children 12 yrs & over2 LiquiCaps with water every 4 hrs
    children 4 to under 12 yrsask a doctor
    children under 4 yrsdo not use

Other Information

  • store at room temperature

Inactive Ingredients

FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, methyl paraben, polyethylene glycol, povidone, propylene glycol, propyl paraben, purified water, sorbitol, titanium dioxide

Questions?

1-866-467-2748

Principal Display Panel - 10 Softgel Carton

Multi-Symptom

 DayTime

Liquid Capsules

Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine HCl

 

Cold/Flu Relief

  • Pain Reliever
  • Fever Reducer
  • Nasal Decongestant
  • Cough Suppressant
  •  

    10 Softgels

    Compare to the active ingredient in Vicks Dayquil®

    Daytime Liquid Capsules Cold/flu Relief 10ct (6cf1fd3d 5529 412d 9003 A06edd445f57 01)

    Daytime Liquid Capsules Cold/flu Relief 10ct (6cf1fd3d 5529 412d 9003 A06edd445f57 01)

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