1. Home
  2. Labeler Index
  3. Puracap Pharmaceutical Llc
  4. 51013-117
  5. Label Information: Cvs Daytime Cold And Flu Relief And Nighttime Cold And Flu Relief

FDA Label for Cvs Daytime Cold And Flu Relief And Nighttime Cold And Flu Relief

View Indications, Usage & Precautions

Table of Contents

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

Cvs Daytime Cold And Flu Relief And Nighttime Cold And Flu Relief 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)



DAYTIME SEVERE COLD AND FLU 

Acetaminophen 325 mg 

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg 

Phenylephrine HCl 5mg

NIGHTTIME SEVERE COLD AND FLU

Acetaminophen 325 mg 

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg 

Phenylephrine HCl 5mg


Purpose



DAYTIME SEVERE COLD AND FLU

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant


Purposes



NIGHTTIME SEVERE COLD AND FLU

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant


Uses



DAYTIME SEVERE COLD AND FLU RELIEF

  • temporarily relieves common cold/flu symptoms:
  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • minor aches & pains
  • headache
  • fever
  • sore throat
    • reduces swelling of nasal passages
    • temporarily restores freer breathing through the nose
    • promotes nasal and/or sinus drainage
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

      • NIGHTTIME SEVERE COLD AND FLU RELIEF

      • temporarily relieves common cold/flu symptoms:
      • nasal congestion
      • sinus congestion & pressure
      • cough due to minor throat & bronchial irritation
      • cough to help you sleep
      • minor aches & pains
      • headache
      • fever
      • sore throat
      • runny nose & sneezing
        • reduces swelling of nasal passages
        • temporarily restores freer breathing through the nose
        • promotes nasal and/or sinus drainage

Warnings



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 every day while using this product

    • 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.

    Allergy 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.


Do Not Use



DAYTIME SEVERE COLD AND FLU 

  • 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.

    • NIGHTTIME SEVERE COLD AND FLU 

    • 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

Ask A Doctor Before Use If You Have



DAYTIME SEVERE COLD AND FLU

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    • NIGHTTIME SEVERE COLD AND FLU

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • glaucoma
    • 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 enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are



  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When Using This Product



  • do not use more than directed
  • 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
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • 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 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 as well as 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 and  over

            2 softgels with water every 4 hrs

    children 4 to under 12 yrs

            ask a doctor

    children under 4 yrs

            do not use

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

Other Information



  • store at room temperature and avoid excessive heat

Inactive Ingredients



DAYTIME SEVERE COLD AND FLU

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

NIGHTTIME SEVERE COLD AND FLU

FD&C blue #1, D&C yellow #10, 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



CVS Daytime COLD & FLU RELIEF and Nighttime COLD & FLU RELIEF

NDC 51013-117-04

*Compare to the active ingredients in Vicks® DayQuil® Severe and NyQuil® Severe Cold and Flu


* Please review the disclaimer below.