1. Home
  2. Labeler Index
  3. Puracap Pharmaceutical Llc
  4. 51013-124
  5. Label Information: Daytime And Nitetime

FDA Label for Daytime And Nitetime

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH SOFTGEL)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. OVERDOSE WARNING
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL

Daytime And Nitetime Product Label

The following document was submitted to the FDA by the labeler of this product Puracap Pharmaceutical Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients (In Each Softgel)



Active ingredients for DayTime (in each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Active ingredients for NiteTime (in each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg


Purpose



DayTime Liquid Capsules

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

NiteTime Liquid Capsules

Pain reliever/fever reducer

Cough suppressant 

Antihistamine


Uses



temporarily relieves common cold/flu symptoms:

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

Warnings



Liver warning

These products contain acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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. 
  • to make a child sleep (NiteTime 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)
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with excessive phlegm (mucus)    
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema, and (for NiteTime only) chronic bronchitis
  • glaucoma (NiteTime only)

Ask A Doctor Or Pharmacist Before Use If You Are



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

When Using This Product



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

In addition, when using NiteTime:

  • 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 and (for DayTime only) nasal congestion gets worse or last more than 7 days
  • redness or swelling is present
  • 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.


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
  • swallow whole; do not crush, chew, or dissolve
  • do not exceed 4 doses per 24 hours                                                                                              
    • Age DayTimeNiteTime
     adults and children 12 years of age and over take 2 softgels with water every 4 hours take 2 softgels with water every 6 hours
     children 4 to under 12 years of age ask a doctor ask a doctor
     children under 4 years of agedo not usedo not use

    When using other DayTime or NiteTime 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



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

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


Questions Or Comments?



Call toll free: 1-855-215-8180


Principal Display Panel



ASSURED DayTime and NiteTime Liquid Capsules

Combo Pack 12 count

NDC 51013-124-02

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

Carton Label - DT07 01

Carton Label - DT07 01


* Please review the disclaimer below.