NDC | 0067-2086-01, 0067-2086-05, 0067-2086-15, 0067-2086-62 |
Set ID | a8fc41c7-4425-41b8-b1c6-eb22ac054734 |
Category | HUMAN OTC DRUG LABEL |
Packager | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Active ingredient
- Purpose
- Uses
temporarily relieves nasal congestion due to:
- •
- common cold
- •
- hay fever
- •
- upper respiratory allergies
- 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 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.
- Directions
- •
- 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?
- Principal Display
NDC 0067-2086-01
4 way
Fast Acting
Phenylephrine Hydrochloride 1%Nasal Decongestant
Fast Relief of:
- 1.
- Nasal Congestion
- 2.
- Swollen Nasal Membranes
- 3.
- Sinus Congestion
- 4.
- Sinus Pressure
Nasal Spray
1 fl oz (29.6 mL)
DO NOT USE IF PERFORATED OVERWRAP PRINTED WITH GSK
LOGO AROUND THE CAP OR BOTTLE IS BROKEN OR MISSING1-855-221-5428
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.
13183
Made in Canada
Close - INGREDIENTS AND APPEARANCE
4 WAY FAST ACTING
phenylephrine hydrochloride sprayProduct 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)