FDA Label for Cvs Severe Cough, Flu Plus Sore Throat Honey

View Indications, Usage & Precautions

Cvs Severe Cough, Flu Plus Sore Throat Honey Product Label

The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. 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 20 Ml)



Acetaminophen, USP 650 mg

Dextromethorphan HBr, USP 20 mg


Purposes



Pain reliever/Fever reducer

Cough suppressant


Indications & Usage



Uses

  • •temporarily relieves these symptoms occurring with a cold or flu:
    • •cough due to minor throat and bronchial irritation
    • •minor aches and pains
    • •sore throat pain
    • •headache
    • •temporarily reduces fever

Warnings



Warnings


Liver Warning



This product contains acetaminophen.

Severe liver damage may occur if you take

  • •more than 6 doses in any 24-hour period, which is the maximum daily amount
  • •with other drugs containing acetaminophen
  • •3 or more alcoholic drinks every day while using this product

Other



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.

    Distributed by:


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



  • •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.
  • •with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask A Doctor Before Use If You Have



  • •liver disease
  • •cough that occurs with too much phlegm (mucus)
  • •a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are



  • •taking the blood thinning drug warfarin
  • •taking any other pain reliever/fever reducer

Otc - When Using



When using this product do not use more than directed.


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.

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. 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.


Dosage & Administration



Directions

  • •do not take more than 6 doses in any 24-hour period
  • •do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
  • •measure only with dosing cup provided
  • •keep dosing cup with product
  • •ml = milliliter
  • •this adult product is not intended for use in children under 12 years of age
  • agedose

    adults and children 12 years and over

    20 ml every 4 hours

    children under 12 years

    do not use


Storage And Handling



Other information

  • •each 20 ml contains: sodium 10 mg
  • •store at room temperature

Inactive Ingredient



Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, disodium edetate, elderberry extract, flavors, glycerin, organic wildflower honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum, zinc gluconate


Otc - Questions



Questions or comments?

1-866-467-2748


Principal Display Panel



NDC 51316-631-08

SEVERE

Daytime
Cough, Flu +
Sore Throat

With Honey

Acetaminophen (Pain Reliever/Fever Reducer)
Dextromethorphan HBr (Cough Suppressant)

Maximum Strength

* Please review the disclaimer below.