NASAL DECONGESTANT- oxymetazoline hydrochoride solution/ drops

Nasal Decongestant by

Drug Labeling and Warnings

Nasal Decongestant by is a Otc medication manufactured, distributed, or labeled by THE IBN SINA PHARMACEUTICAL INDUSTRY LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Oxymetazoline hydrochloride 0.05%

PURPOSE

Purpose

Nasal decongestant

INDICATIONS & USAGE

Uses

• temporarily relieves nasal congestion due to:
• common cold
• hay fever
• upper respiratory allergies

WARNINGS

Warnings

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

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

STOP USE

Stop use and ask a doctor if symptoms persist

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

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.

QUESTIONS

Questions?

1-833-IBN-SINA (1-833-426-7462)

SPL UNCLASSIFIED SECTION

Manufactured by:

The IBN SINA Pharmaceutical Industry Ltd.

Holding # A-80, Ward # 9, Shafipur, Kaliakoir,

Gazipur-1751, Bangladesh

www.ibnsinapharma.com

Product of Bangladesh

PRINCIPAL DISPLAY PANEL

NDC: 72103-333-15

NASAL DECONGESTANT

Oxymetazoline HCL 0.05% Nasal Solution

Helps relieve congestion

0.34 FL OZ (10 mL)

INGREDIENTS AND APPEARANCE

NASAL DECONGESTANT 
oxymetazoline hydrochoride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72103-333
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72103-333-15	1 in 1 CARTON	03/12/2019
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/12/2019

Labeler - THE IBN SINA PHARMACEUTICAL INDUSTRY LTD. (731557752)

Establishment
Name	Address	ID/FEI	Business Operations
THE IBN SINA PHARMACEUTICAL INDUSTRY LTD.		731557752	manufacture(72103-333)