Label: 4 WAY FAST ACTING- phenylephrine hydrochloride spray
- NDC Code(s): 0067-2086-01, 0067-2086-05, 0067-2086-15, 0067-2086-62
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated April 9, 2018
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- Active ingredient
Phenylephrine Hydrochloride 1%Close
temporarily relieves nasal congestion due to:
- common cold
- hay fever
- upper respiratory allergies
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
When using this product
- do not use more than directed
- do not use more than 3 days
- use only as directed
- frequent or prolonged use may cause nasal congestion to recur or worsen
- temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
- infection may spread if this container is used by more than one person
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
- adults and children 12 years of age and over: 2 or 3 sprays in each nostril not more often than every 4 hours
- children under 12 years of age: ask a doctor
- Use instructions: with head in a normal, upright position, put atomizer tip into nostril. Squeeze bottle with firm, quick pressure while inhaling. Wipe nozzle clean after each use.
- Other information
- store at controlled room temperature 20°-25°C (68°-77°F)
- Inactive ingredients
benzalkonium chloride solution, boric acid, purified water, sodium borateClose
- Questions or Comments?
- Principal Display
Phenylephrine Hydrochloride 1%
Fast Relief of:
- Nasal Congestion
- Swollen Nasal Membranes
- Sinus Congestion
- Sinus Pressure
1 fl oz (29.6 mL)
DO NOT USE IF PERFORATED OVERWRAP PRINTED WITH GSK
LOGO AROUND THE CAP OR BOTTLE IS BROKEN OR MISSING
Trademarks are owned by or licensed to the GSK group of companies.
Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
©2017 GSK group of companies or its licensor.
Made in CanadaClose
- INGREDIENTS AND APPEARANCE
4 WAY FAST ACTING
phenylephrine hydrochloride spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-2086 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BORIC ACID (UNII: R57ZHV85D4) SODIUM BORATE (UNII: 91MBZ8H3QO) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-2086-01 1 in 1 CARTON 01/01/2010 1 29.6 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 2 NDC:0067-2086-05 1 in 1 CARTON 01/01/2010 10/31/2013 2 14.8 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 3 NDC:0067-2086-62 1 in 1 CARTON 01/01/2010 10/31/2013 3 18.5 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 4 NDC:0067-2086-15 1 in 1 CARTON 01/01/2010 01/31/2010 4 37 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 01/01/2010 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)