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  5. Label Information: Night-time Cough Relief

FDA Label for Night-time Cough Relief

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTSACTIVE INGREDIENTS (IN EACH 30 ML DOSE CUP)
    2. PURPOSE
    3. KEEP OUT OF REACH OF CHILDREN
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. ASK A DOCTOR BEFOR USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE
    9. WHEN USING THIS PRODUCT
    10. STOP USE AND ASK A DOCTOR IF
    11. IF PREGNANT OR BREAST FEEDING,
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS ?
    16. DISCOUNT DRUG MARTFOOD FAIRCHERRYNIGHT-TIMECOUGH REFIEF PRODUCT LABEL

Night-time Cough Relief Product Label

The following document was submitted to the FDA by the labeler of this product Discount Drug Mart. 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.

Drug Factsactive Ingredients (In Each 30 Ml Dose Cup)



Dextromethorphan HBr 30 mg

Doxylamine Succinate 12.5 mg


Purpose



Cough suppressant

Antihistamine


Keep Out Of Reach Of Children



Keep out of reach of children.


Uses



temporarily relieves cold symptoms:

  • runny nose and sneezing
  • cough

Warnings



DO NOT USE IF IMPRINTED SHRINK BRAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences.


Do Not Use



  • if you are now taking a prescription monamine 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 sleepy

Ask A Doctor Befor Use If You Have



  • a sodium restricted diet
  • 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

When Using This Product



  • do not use more than directed
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • 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 lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

If Pregnant Or Breast Feeding,



ask a health professionalbefore use.


Directions



  • Use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours
  • When using Day Time and Night Time products, carefully read each label to ensure
    •  adults and children 12 years and over 30 mL (2 TBSP) every 6 hours
     children 4 to under 12 years ask a doctor
     children under 4 years do not use


Other Information



  • each 30 mL dose cup contains: sodium 45 mg
  • store at room temperature

Inactive Ingredients



citric acid, FD and C Blue No. 1, FD and C Red No. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose


Questions ?



Call weekdays from 9:30 am to 4:30 pm EST.

1-877-798-5944.


Discount Drug Martfood Faircherrynight-Timecough Refief Product Label



*COMPARE TO THE INGREDIENTS IN VICKS® NYQUIL® COUGH

DISCOUNT

drug mart

FOOD FAIR

Cherry

Night-Time

COUGH RELIEF

Dextromethorphan HBr ..... Cough Suppressant

Doxylamine Succiate ......... Antihistamine

  • Cough
  • Sneezing
  • Runny Nose

    • 12 FL OZ (354 mL)

    * This product is not manufactured or distributed by Proctor and Gamble owner of the registered trademark Vicks® Nyquil® Cough

    LR-067

    SATISFACTION GUARANTEED

    IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO THE STORE WHERE PURCHASED. IF UNABLE TO RETURN TO THE STORE, SEND REASON FOR DISSATISFACTION ,  NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE MEDINNA, OHIO 44256


* Please review the disclaimer below.