Other
Drug Facts
Manufactured by:
The IBN SINA Pharmaceutical Industry Ltd.
Holding # A-80, Ward # 9, Shafipur, Kaliakoir,
Gazipur-1751, Bangladesh
www.ibnsinapharma.com
Product of Bangladesh
Nasal Decongestant
FDA Label NDC 72103-333
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Ibn Sina Pharmaceutical Industry Ltd. for the product Nasal Decongestant (NDC 72103-333). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Oxymetazoline hydrochloride 0.05%
Otc - Purpose
Purpose
Nasal decongestant
Indications & Usage
Uses
- temporarily relieves nasal congestion due to:
- common cold
- hay fever
- upper respiratory allergies
Warnings
Warnings
Otc - Ask Doctor
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
Otc - When Using
When using this product
- do not exceed recommended dosage
- do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen
- it may cause temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge
- use of this container by more than one person may spread infection
Otc - Stop Use
Stop use and ask a doctor if symptoms persist
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 (1-800-222-1222) right away.
Dosage & Administration
Directions
- Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 drops in each nostril not more often than every 10-12 hours. Do not exceed 2 doses in any 24-hour period.
- Children under 6 years of age: consult a doctor.
Storage And Handling
Other information
- store between 15° to 30°C (59° to 86°F)
- TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL ON BOTTLE OR DROPPER TIP IS LOOSE, BROKEN OR MISSING
Inactive Ingredient
Inactive ingredients
benzalkonium chloride, edetate disodium, glycerin, potassium phosphate monobasic, sodium chloride, sodium phosphate dibasic dihydrate, water.
Otc - Questions
Questions?
1-833-IBN-SINA (1-833-426-7462)
Package Label.Principal Display Panel
NDC 72103-333-15
NASAL DECONGESTANT
Oxymetazoline HCL 0.05% Nasal Solution
Helps relieve congestion
0.34 FL OZ (10 mL)
* Please review the disclaimer below.
