DRISTAN 12 HR- oxymetazoline hydrochloride spray

Dristan by

Drug Labeling and Warnings

Dristan by is a Otc medication manufactured, distributed, or labeled by Foundation Consumer Brands. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Oxymetazoline hydrochloride 0.05%

Purpose

Nasal decongestant

Uses

• temporarily relieves nasal congestion due to a cold, hay fever or other upper respiratory allergies
• shrinks swollen membranes
• temporarily restores freer breathing through the nose
• temporarily relieves sinus congestion and pressure

Warnings

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 use more than directed
• do not use for more than 3 days
• use only as directed
• frequent or prolonged use may cause nasal congestion to recur or worsen
• may cause temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge
• the use of this container by more than one person may spread infection

Stop use and ask a doctor if symptoms persist

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 6 to under 12 years of age (with adult supervision): 2 to 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
• children under 6 years of age: ask a doctor To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Replace cap tightly to maintain child resistant closure.

Other information

• store at 20-25°C (68-77°F)
• container is filled to proper level for correct spray action
• retain carton for full labeling

Inactive ingredients

benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate, edetate disodium, hypromellose, phosphoric acid, purified water, sodium chloride

Questions or comments?

Call 1-888-594-0710 weekdays 9 AM to 5 PM EST

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Distributed by:
Foundation Consumer Brands, LLC
Pittsburgh, PA 15212

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

Dristan®
12
HOUR
NASAL
SPRAY

Oxymetazoline HCl 0.05%
Nasal Decongestant

Fast Acting Relief
Sinus & Nasal
Congestion

Relieves:

• ✓ Sinus Congestion & Pressure
• ✓ Nasal Congestion due to
  Colds & Allergies
• ✓ Swelling of Nasal Passages

0.5 FL OZ (15 mL)

INGREDIENTS AND APPEARANCE

DRISTAN   12 HR
oxymetazoline hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80070-400
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY)	OXYMETAZOLINE HYDROCHLORIDE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
PHOSPHORIC ACID (UNII: E4GA8884NN)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Product Characteristics
Color	YELLOW (clear, colorless to slightly yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80070-400-05	1 in 1 CARTON	08/17/2021
1		15 mL in 1 BOTTLE, SPRAY; 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	08/17/2021

Labeler - Foundation Consumer Brands (117603632)