FDA Label for Delsym No Mess Vapor Roll On

View Indications, Usage & Precautions

Delsym No Mess Vapor Roll On 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


Otc - Purpose



Active ingredientsPurpose
Camphor 5.3%Cough suppressant/topical analgesic
Eucalyptus oil 1.3%Cough suppressant
Menthol 2.8%Cough suppressant/topical analgesic

Uses



temporarily relieves

  • cough due to minor throat and bronchial irritation as may occur with the common cold
  • cough to help you sleep
  • minor aches and pains of muscles and joints

Warnings



For external use only


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)

When Using This Product



  • do not heat, microwave, or add to hot water or any container where heating water. May cause splattering and result in burns
  • do not take by mouth or place in nostrils
  • do not bandage tightly
  • avoid contact with eyes
  • do not apply to wounds or damaged skin

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.
  • muscle aches and pains worsen, persist for more than 7 days, or clear up and occur again within a few days

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. If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • see important warnings under "When using this product"
  • adults and children 2 years of age and older
  • for cough, apply a thick layer on the throat and chest
  • cover with a warm, dry cloth if desired
  • clothing should be loose about throat and chest to help vapors reach the nose and mouth
  • for muscle aches and pains, apply to affected area
  • use up to three times daily or as directed by a doctor
  • children under 2 years: ask a doctor

Other Information



  • store at 20-25°C (68-77°F)

Inactive Ingredients



fragrance, glyceryl dibehenate, light mineral oil, octyldodecyl olivate, petrolatum


Questions?



1-866-682-4639

You may also report side effects to this phone number.


Principal Display Panel - 50 G Container Carton



NEW
NDC 72854-352-01

Delsym®

NO MESS
VAPOR
ROLL-ON
Cough Suppressant & Topical Analgesic
COUGH RELIEF

100%
Natural
Camphor, Eucalyptus Oil,
Menthol

Ointment

Ages 2+

NET WT 1.76 OZ (50 g)


* Please review the disclaimer below.