FDA Label for Signature Care Daytime Cough

View Indications, Usage & Precautions

Signature Care Daytime Cough Product Label

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



Dextromethorphan HBr 15 mg


Purpose



Cough suppressant


Use



temporarily relieves cough due to minor throat and bronchial irritation associated with a cold


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.


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, or emphysema

Stop Use And Ask A Doctor If



cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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



  • •take only as directed
  • •use dose cup
  • •do not exceed 4 doses per 24 hours
  • adults and children 12 years and over

    30 mL every 6-8 hours

    children 6 to under 12 years

    15 mL every 6-8 hours

    children 4 to under 6 years

    ask a doctor

    children under 4 years

    do not use


Other Information



  • each 15 mL contains: sodium 13 mg
  • •store at 20-25°C (68-77°F)
  • •does not meet USP requirements for light resistant packaging

Inactive Ingredients



anhydrous citric acid, D&C yellow #10, FD&C yellow #6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate


Questions Or Comments?



1-888-723-3929


Principal Display Panel



Non-Drowsy Daytime Cough

Dextromethorphan HBr – Cough Suppressant

CITRUS BLEND FLAVOR

Compare to Vicks® DayQuil® Cough active ingredient

All day cough relief up to 8 hours

Antihistamine free

Alcohol free

12 FL OZ (355 mL)


* Please review the disclaimer below.