FDA Label for Cvs Health Non-drowsy Nasal Decongestant

View Indications, Usage & Precautions

Cvs Health Non-drowsy Nasal Decongestant Product Label

The following document was submitted to the FDA by the labeler of this product Westport Pharmaceuticals. 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.

Otc - Active Ingredient



Active Ingredients (in each pill)

Pseudoephedrine HCl 30 mg


Otc - Purpose



Purpose

Nasal Decongestant


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. (1-800-222-1222)


Indications & Usage



Uses

  • temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies
  • temporarily relieves sinus congestion and pressure

Warnings



Warnings

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

• heart disease • high blood pressure • thyroid disease • diabetes

• trouble urinating due to an enlarged prostate gland

When using this product do not exceed recommended dose

Stop and ask a doctor if

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever
  • If pregnant or breast-feeding, ask a health professional before use.


Dosage & Administration



Directions: remove pill from sealed, plastic packaging before ingesting

swallow whole – do not crush, chew or dissolve

adults and children 12 years and over • take 2 pills every 4 to 6 hours

• do not take more than 8 pills in 24 hours

children ages 6 to under 12 years • take 1 pill every 4 to 6 hours

• do not take more than 4 pills in 24 hours

children ages under 6 years do not use this product in children

under 6 years of age


Inactive Ingredient



Inactive Ingredients croscarmellose sodium, guar gum, hydroxypropyl cellulose, lecithin,

microcrystalline cellulose, polyethylene glycol, sorbitan monooleate, vegetable oil, xanthan gum


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