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  5. Label Information: Delsym Cough Relief Plus Soothing Action

FDA Label for Delsym Cough Relief Plus Soothing Action

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. SORE THROAT WARNING
    5. OTC - DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. STOP USE AND ASK A DOCTOR OR DENTIST IF
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS?
    14. PRINCIPAL DISPLAY PANEL - 16 LOZENGE CARTON

Delsym Cough Relief Plus Soothing Action Product Label

The following document was submitted to the FDA by the labeler of this product Reckitt Benckiser 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.

Other



Drug Facts

Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224


Otc - Purpose



Active ingredients (in each lozenge)Purpose
Dextromethorphan HBr 5 mgCough suppressant
Menthol 5 mgOral pain reliever

Uses



temporarily relieves

  • sore throat
  • sore mouth
  • minor mouth irritation
  • cough due to minor throat and bronchial irritation as may occur with the common cold

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.

Otc - Do Not Use



Do not use in a child under 6 years of age.

Do not use if you are now taking 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



  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that is accompanied by excessive phlegm (mucus)

Stop Use And Ask A Doctor Or Dentist If



  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling develops
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness

Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



Keep this and all drugs out of the reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.


Directions



  • adults and children 12 years and older: take 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 12 lozenges in any 24-hour period, or as directed by a doctor
  • children 6 to under 12 years of age: take 1 lozenge and allow to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 6 lozenges in 24 hours, or as directed by a doctor
  • children under 6 years of age: do not use

Other Information



  • tamper evident: product is sealed in blister package for your protection. Do not use if carton is damaged or if printed seal on blister is broken or missing.
  • store at room temperature 20–25°C (68–77°F)

Inactive Ingredients



D&C yellow #10, FD&C yellow #6, flavors, liquid glucose, propylene glycol, sucralose, sucrose, water


Questions?



Call 1-888-963-3382

You may also report side effects to this phone number.


Principal Display Panel - 16 Lozenge Carton



NDC 63824-160-16
NEW!

Delsym®

COUGH RELIEF PLUS
SOOTHING ACTION

Dextromethorphan HBr 5 mg (Cough Suppressant)
Menthol 5 mg (Oral Pain Reliever)

* Please review the disclaimer below.