Ibn Oxymetazoline Nasal Solution

Ibn Oxymetazoline Nasal Solution
SPL v2
SPL
SPL Set ID 711f099d-0690-5d03-e053-2a95a90a1755
Route
NASAL
Published
Effective Date 2019-03-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxymetazoline (0.05 g)
Inactive Ingredients
Benzalkonium Chloride Edetic Acid Sodium Chloride Sodium Phosphate, Dibasic, Dihydrate Potassium Phosphate, Monobasic Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-03-12

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

  • temporarily relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies
Dosage and 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.
Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

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
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

Stop use and ask a doctor if symptoms persist

Section 50567-7

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
Section 50569-3

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
Section 51727-6

Inactive ingredients

benzalkonium chloride, edetate disodium, glycerin, potassium phosphate monobasic, sodium chloride, sodium phosphate dibasic dihydrate, water.

Section 51945-4

NDC 72103-333-15

NASAL DECONGESTANT

Oxymetazoline HCL 0.05% Nasal Solution

Helps relieve congestion

0.34 FL OZ (10 mL)

Section 53413-1

Questions?

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

Section 53414-9

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

Section 55105-1

Purpose

Nasal decongestant

Section 55106-9

Active ingredient

Oxymetazoline hydrochloride 0.05%


Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves nasal congestion due to:
  • common cold
  • hay fever
  • upper respiratory allergies
Dosage and Administration (34068-7)

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.
Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

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
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if symptoms persist

Section 50567-7 (50567-7)

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
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
Section 51727-6 (51727-6)

Inactive ingredients

benzalkonium chloride, edetate disodium, glycerin, potassium phosphate monobasic, sodium chloride, sodium phosphate dibasic dihydrate, water.

Section 51945-4 (51945-4)

NDC 72103-333-15

NASAL DECONGESTANT

Oxymetazoline HCL 0.05% Nasal Solution

Helps relieve congestion

0.34 FL OZ (10 mL)

Section 53413-1 (53413-1)

Questions?

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredient

Oxymetazoline hydrochloride 0.05%


Advanced Ingredient Data


Raw Label Data

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