Label: NASAL- phenylephrine hydrochloride spray
- NDC Code(s): 30142-539-10
- Packager: Kroger Company
- 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 March 2, 2021
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have
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- heart disease
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- diabetes
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- thyroid disease
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- high blood pressure
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- trouble urinating due to an enlarged prostate gland
When using this product
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- do not use more than directed
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- do not use for more than 3 days. Frequent or prolonged use may cause nasal congestion to come back or get worse.
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- use only as directed
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- temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
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- use of this container by more than one person may spread infection
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Directions
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- adults and children 12 years and over: 2 or 3 sprays in each nostril not more often than every 4 hours
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- children under 12 years: ask a doctor
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- 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?
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Principal Display Panel
COMPARE TO the active ingredient of 4-WAY® FAST ACTING NASAL SPRAY
See side panel
OUR PHARMACIST RECOMMENDED
Fast Acting
Nasal Spray
Phenylephrine Hydrochloride 1%
Nasal Decongestant
FAST RELIEF OF:
Nasal Congestion
Swollen Nasal Membranes
Sinus Congestion
Sinus Pressure
4 HOUR RELIEF
1 FL OZ (30 mL)
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INGREDIENTS AND APPEARANCE
NASAL
phenylephrine hydrochloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-539 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 1 g in 100 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:30142-539-10 1 in 1 CARTON 02/18/2014 1 30 mL in 1 BOTTLE; 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 02/18/2014 Labeler - Kroger Company (006999528)