1. Home
  2. Labeler Index
  3. Publix Super Markets Inc
  4. 56062-668
  5. Label Information: Nitetime Cough

FDA Label for Nitetime Cough

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 30 ML)
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. PRINCIPAL DISPLAY PANEL

Nitetime Cough Product Label

The following document was submitted to the FDA by the labeler of this product Publix Super Markets Inc. 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 30 Ml)



Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg


Purpose



Cough suppressant

Antihistamine


Uses



temporarily relieves cold symptoms:

  • •cough due to minor throat and bronchial irritation
  • •runny nose and sneezing

Do Not Use



  • •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



  • •glaucoma
  • •cough that occurs with too much phlegm (mucus)
  • •a breathing problem such as emphysema or chronic bronchitis
  • •persistent or chronic cough as occurs with smoking, asthma, or emphysema
  • •trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are



taking sedatives or tranquilizers


When Using This Product



  • •excitability may occur, especially in children
  • •may cause marked drowsiness
  • •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



cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.


If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Directions



  • •take only as directed
  • •only use the dose cup provided
  • •do not exceed 4 doses per 24 hrs

    • adults & children 12 yrs & over

    30 mL every 6 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use


Other Information



  • •each 30 mL contains: sodium 32 mg
  • •store at 20-25°C (68-77°F)

Inactive Ingredients



alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate


Principal Display Panel



COUGH RELIEF

nighttime

COUGH SUPPRESSANT, ANTIHISTAMINE

DEXTROMETHORPHAN HBr – COUGH

DOXYLAMINE SUCCINATE – SNEEZING, RUNNY NOSE

ALCOHOL 10%

CHERRY FLAVOR

Compare to the active ingredients in Vicks® NyQuil®Cough

12 FL OZ (355 mL)


* Please review the disclaimer below.