FDA Label for Cvs Children Decongestant Nose Drops
View Indications, Usage & Precautions
Cvs Children Decongestant Nose Drops Product Label
The following document was submitted to the FDA by the labeler of this product Tai Guk Pharm. Co., Ltd.. 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 ingredient Purpose
Phenylephrine Hydrochloride USP 0.125%...................Nasal Decongestant
Otc - Purpose
Uses
- temporarily relieves nasal congestion, due to common cold, hay fever, or other upper respiratory allergies
- helps clear nasal passages; shrinks swollen membranes
- temporarily restores freer breathing through the nose
- helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure
Warnings
Warnings
- do not exceed recommended dosage
- do not use with any other products containing decongestants
Otc - Ask Doctor
Ask a doctor before use if the child has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
Otc - When Using
When using this product temporary discomfort may occur such as:
- burning
- stinging
- sneezing
- increase in nasal discharge
- the use of this dispenser by more than one person may spread infection
Otc - Stop Use
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occurs
- symptoms persist. Do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
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.
Indications & Usage
Directions (Nasal use only)
- children 2 to under 6 years (with adult supervision): 2 to 3 drops into each nostril, not more often than every 4 hours
- children under 2 years of age: Consult a physician
Storage And Handling
Other information
- do not use if solution is brown or contains a precipitate
- protect from light
- store at 20-25oC (68-77oF)
- see bottle or box for lot number and expiration date
Inactive Ingredient
Inactive ingredients
Benzalkonium Chloride, Edetate Disodium, Glycerin, Polyethylene Glycol, Potassium Phosphate Monobasic, Purified Water, Sodium Phosphate Dibasic
Package Label.Principal Display Panel
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