FDA Label for Cough Dm

View Indications, Usage & Precautions

Cough Dm Product Label

The following document was submitted to the FDA by the labeler of this product Meijer Distribution Inc. 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 Ingredient (In Each 5 Ml)



Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide


Purpose



Cough suppressant


Uses



temporarily relieves

  • •cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • •the impulse to cough to help you get to sleep

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.

Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.


Ask A Doctor Before Use If You Have



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

Stop Use And Ask A Doctor If



  • •side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
  • •cough lasts more than 7 days, cough 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 professional before use.


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222.


Directions



  • •shake bottle well before use
  • •measure only with dosing cup provided. Do not use dosing cup with other products.
  • •dose as follows or as directed by doctor
  • •mL = milliliter
  • adults and children 12 years of age and over

    10 mL every 12 hours, not to exceed 20 mL in 24 hours

    children 6 to under 12 years of age

    5 mL every 12 hours, not to exceed 10 mL in 24 hours

    children 4 to under 6 years of age

    2.5 mL every 12 hours, not to exceed 5 mL in 24 hours

    children under 4 years of age

    do not use


Other Information



  • •each 5 mL contains: sodium 5 mg
  • •store at 20° to 25°C (68° to 77°F)
  • •dosing cup provided

Inactive Ingredients



D&C Red #30 aluminum lake, D&C Yellow #10 aluminum lake, flavor, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



Compare to Children’s Delsym® active ingredient

Age 4+

12 Hour Cough Relief

children’s Cough DM

Dextromethorphan Polistirex

Extended-Release Oral Suspension

Cough Suppressant

Orange-Flavored Liquid

Day or Night

Alcohol-Free

Dosing Cup Included

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions

5 FL OZ (148 mL)

for Children & Adults


* Please review the disclaimer below.