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  5. Label Information: Delsym Cough

FDA Label for Delsym Cough

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH CAPLET)
    3. PURPOSE
    4. USE
    5. OTC - DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. OTC - STOP USE
    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 - 20 CAPLET BLISTER PACK CARTON

Delsym Cough Product Label

The following document was submitted to the FDA by the labeler of this product Rb Health (us) 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: RB Health (US)
Parsippany, NJ 07054-0224
Made in India


Active Ingredient (In Each Caplet)



Dextromethorphan HBr 15 mg


Purpose



Cough suppressant


Use



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

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.


Ask A Doctor Before Use If You Have



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

Otc - Stop Use



Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with 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.


Directions



  • dose as follows or as directed by a doctor
  • adults and children 12 years of age and over:
    take 2 caplets every 6 to 8 hours as needed, not to exceed 8 caplets in 24 hours
  • children under 12 years of age:
    do not use

Other Information



  • store at 20-25°C (68-77°F)

Inactive Ingredients



FD&C yellow no. 6 aluminum lake, hypromellose, isomalt, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, titanium dioxide


Questions?



1-866-682-4639

You may also report side effects to this phone number.


Principal Display Panel - 20 Caplet Blister Pack Carton



MAXIMUM STRENGTH

NEW!

NDC 72854-351-20

Delsym®

COUGH
Dextromethorphan HBr (Cough Suppressant)

LASTS
UP
TO
8HR

DAY
OR
NIGHT

FAST
RELEASE

Actual Size

20 Caplets
For Ages 12+

Principal Display Panel - 20 Caplet Blister Pack Carton - delsym 01

Principal Display Panel - 20 Caplet Blister Pack Carton - delsym 01


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