FDA Label for Cough And Sore Throat Daytime

View Indications, Usage & Precautions

Cough And Sore Throat Daytime Product Label

The following document was submitted to the FDA by the labeler of this product Kinray 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 15 Ml Tablespoon)



Acetaminophen 500 mg

Dextromethorphan HBr 15 mg


Purpose



Pain reliever / Fever reducer

Cough suppressant


Uses



  • sore throat
  • headache
  • minor aches and pains
  • cough due to a cold
  • temporarily relieves fever

Warnings



Alcohol Warning: if you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take Acetaminophen or oter pain releivers/ fever reducers.

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 of 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.


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
  • if you are allergic to acetaminophen or any of the ingredients in this product.

Ask A Doctor Before Use If You Have



  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a sodium-restricted diet

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
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when operating machinery

Stop Use And Ask A Doctor If



  • pain 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.

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



overdose warning: taking more than recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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 recommended - see overdose warning
  • use dose cup or Tabelspoon (TBSP) every 6 hours as needed
  • do not exceed 4 doses in 24-hour period
  • Adults and

    children 12 years of age

    and over
    • take 2 tablespoons (tbsp) 30 ml in dose cup provided every 6 hours as needed
    Children under 12 years
    • do not use this product in children under 12 years of age: this will provide more than the recommended dose (overdose) and may cause liver damage

Other Information



  • Store at room temperature 15°- 30°C (59° - 86°F)
  • Protect from freezing
  • each tablespoon contains: sodium 21 mg
  • TAMPER EVIDENT: DO NOT USE IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING


Inactive Ingredients



carboxy methyl cellulose sodium, citric acid, FD&C Blue #1, flavor, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol and sucrose


Questions Or Comments?



1-845-692-5799


Principal Display Panel



Cough & Sore ThroatCough & Sore Throat

* Please review the disclaimer below.