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.
Drug Label Information
Updated February 26, 2021
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- Active ingredient
Ask a doctor before use if you have
- heart disease
- thyroid disease
- high blood pressure
- 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. Frequent or prolonged use may cause nasal congestion to come back or get worse.
- use only as directed
- temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
- use of this container by more than one person may spread infection
- 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
- Inactive ingredients
- Questions or Comments?
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 PRINTED NECKBAND IS BROKEN OR MISSING
Trademarks are owned by or licensed to the GSK group of companies.
Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
©2020 GSK group of companies or its licensor.
Made in Japan
64810SBC1 Front Carton
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) BENZYL ALCOHOL (UNII: LKG8494WBH) 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)