FDA Label for Night-time Multi-symptom Cold/flu Cherry

View Indications, Usage & Precautions

Night-time Multi-symptom Cold/flu Cherry Product Label

The following document was submitted to the FDA by the labeler of this product Demoulas Market Basket. 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)



Acetaminophen 650 mg   
Dextromethorphan HBr 30 mg   
Doxylamine Succinate 12.5 mg  


Purpose




Pain reliever/fever reducer   
Cough suppressant   
Antihistamine  


Keep Out Of Reach Of Children



Keep out of reach of children.


Uses



temporarily relieves cold/flu symptoms:

  • sore throat
  • minor aches and pain
  • runny nose and sneezing
  • cough due to minor sore throat and bronchial irritation
  • headache
  • fever

Warnings




Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product.
  • Allergy Alert: Acetaminophen may causesevere skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash
    • If a skin reactions occurs, stop and seek medical help right away.


      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.


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 sleepy

Ask A Doctor Before Use If You Have



  • a sodium restricted diet
  • liver disease
  • 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
  • if you are taking the blood thinning drug warfarin

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



  • redness or swelling is present
  • symptoms do not get better within 7 days or are accompanied by a fever
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, headache that lasts

    •  These could be signs of a serious condition.

If Pregnant Or Breast-Feeding



ask a health professional before use.


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



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

1-877-798-5944


Product Label




MARKET BASKET®

"MORE FOR YOUR DOLLAR"

COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® NYQUIL®


NIGHT-TIME

MULTI-SYMPTOM COLD/FLU  RELIEF


Acetaminophen - Pain Reliever/Fever Reducer

Dextromethorphan - Cough Suppressant

Doxylamine Succinate - Antihistamine

Cherry Flavor

12 FL OZ (354 mL)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences

*This product is not manufactured or distributed by Proctor and Gamble, distributor of Vicks® Nyquil®   LR-002

Made in the USA

DISTRIBUTED BY: DEMOULAS SUPERMARKETS INC.
875 EAST STREET - TEWKSBURY, MA 01876

LR - 035 REV01


* Please review the disclaimer below.