Daytime And Nighttime Cold And Flu
FDA Label NDC 51013-196

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Puracap Pharmaceutical Llc for the product Daytime And Nighttime Cold And Flu (NDC 51013-196). 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 active ingredients (in each softgel), purposes, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using these products, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Softgel)

Active ingredients for Nighttime (in each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Active ingredients for Daytime (in each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purposes

NIGHTTIME COLD/FLU LIQUID CAPS

Pain reliever/fever reducer

Cough suppressant 

Antihistamine

DAY TIME COLD/FLU LIQUID CAPS

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
  • runny nose & sneezing (Nighttime only)
  • nasal congestion (Daytime only)

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. 
  • to make a child sleep (Nighttime only)

Ask A Doctor Before Use If You Have

  • liver disease
  • heart disease (Daytime only)
  • thyroid disease (Daytime only)
  • diabetes (Daytime only)
  • high blood pressure (Daytime only)
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to an enlarged prostate gland
  • glaucoma (Nighttime only)

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking sedatives or tranquilizers (Nighttime only)
  • taking the blood thinning drug warfarin

When Using These Products

  • do not use more than directed

    • In addition, when using Nighttime:

    • excitability may occur, especially in children
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery
    • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop Use And Ask A Doctor If

  • you get nervous, dizzy, or sleepless (Daytime only)
  • pain, cough or nasal congestion (Daytime only) gets worse or last more than 7 days
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough comes back, or occurs with rash, or headache that lasts.

    • These could be signs of a serious condition.

Overdose Warning:

Taking more than the recommended dose 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 as well as for children even if you do not notice any signs or symptoms.

Directions

  • take only as directed - see Overdose warning
  • Take Nighttime or Daytime
  • do not exceed 4 doses per 24 hrs         
    • AgeDaytime Nighttime
     adults and children 12 yrs & over 2 softgels with water every 4 hrs 2 softgels with water every 6 hrs
     children 4 to under 12 yrs ask a doctor ask a doctor
     children under 4 yrs do not usedo not use

    • When using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Other Information

  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive Ingredients

Daytime: FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol sorbitan solution and white edible ink

Nighttime: D&C yellow # 10, FD&C blue #1, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol sorbitan solution and white edible ink 

Questions Or Comments?

Call toll free: 1-855-215-8180

Principal Display Panel

Daytime and Nighttime Liquid Capsules 12ct

NDC 51013-196-02

*Compare to the active ingredients in VICKS® DayQuil® and NyQuil® Cold and Flu LiquiCaps®

Carton Label (Pc72 00)

Carton Label (Pc72 00)

* Please review the disclaimer below.