FDA Label for Cvs Sugar Free Adult Cough Plus Chest Congestion Dm

View Indications, Usage & Precautions

Cvs Sugar Free Adult Cough Plus Chest Congestion Dm 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)



Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg


Purposes



Cough suppressant

Expectorant


Indications & Usage



Uses

  • ▪temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • ▪helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Warnings



Warnings


Otc - Do Not Use



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.


Otc - Ask Doctor



Ask a doctor before use if you have

  • ▪cough that occurs with too much phlegm (mucus)
  • ▪cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Otc - Stop Use



Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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 at 1-800-222-1222.


Dosage & Administration



Directions

  • ▪do not take more than 6 doses in any 24-hour period
  • ▪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
  • age

    dose

    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 7 mg
  • •store at room temperature. Do not refrigerate.

Inactive Ingredient



Inactive ingredients

anhydrous citric acid, disodium edetate, FD&C Red No 40, flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum


Otc - Questions



Questions or comments?

1-866-467-2748


Principal Display Panel



Compare to the active ingredients in Adult Robitussin® Sugar-Free Cough + Chest Congestion DM*
NDC 51316-749-08

SUGAR-FREE

Adult

Cough+Chest
Congestion DM

Dextromethorphan HBr (Cough Suppressant)
Guaifenesin (Expectorant)

  • •Controls Cough
  • •Relieves Chest Congestion
  • •Thins & Loosens Mucus

  • Specially
    Formulated
    for DIABETICS

    For Ages 12 & Over
    8 FL OZ (237 ml)

    Distributed by:

    *This product is not manufactured or distributed by GSK Consumer Healthcare, owner of the registered trademark Adult Robitussin® Sugar-Free Cough+Chest Congestion DM.


* Please review the disclaimer below.