Nasal Spray Congestion Relief Lil' Drug Store® Products

Nasal Spray Congestion Relief Lil' Drug Store® Products

Drug Labeling and Warnings

Drug Details

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CONGESTION RELIEF  LIL DRUG STORE PRODUCTS- oxymetazoline hydrochloride spray 
Lil' Drug Store Products, Inc

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.

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Nasal Spray Congestion Relief
Lil' Drug Store® Products

Drug Facts

Active ingredient

Oxymetazoline Hydrochloride 0.05%

Purpose

Nasal decongestant

Uses

  • Temporarily relieves nasal congestion due to:
    • common cold
    • hay fever
    • upper respiratory allergies
  • Shrinks swollen nasal membranes so you can breathe more freely

Warnings

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • 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.
  • 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.

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 (1-800-222-1222) right away.

Directions

  • adults and children 6 to under 12 years of age (with adult supervision): 2 or 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: consult a doctor

To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

Other information

  • store between 20° to 25°C (68° to 77°F)
  • retain carton for future reference on full labeling

Inactive ingredients

benzalkonium chloride solution, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate monobasic, sodium phosphate dibasic

Questions or comments

call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Product distributed by:
Lil' Drug Store Products, Inc.
1201 Continental Place NE
Cedar Rapids, IA 52402

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

QUALITY
⋆GUARANTEED⋆

Compare to the Active
Ingredient in Afrin®*

Original
Nasal Spray

Oxymetazoline HCl 0.05% Nasal Solution
Nasal Decongestant

Congestion Relief

  • Fast
  • Powerful
  • Long-lasting

12
hour
relief

1 FL OZ
(30 mL)

Lil'
Drug Store®

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
CONGESTION RELIEF   LIL DRUG STORE PRODUCTS
oxymetazoline hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 66715-6860
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Oxymetazoline Hydrochloride (UNII: K89MJ0S5VY) (Oxymetazoline - UNII:8VLN5B44ZY) Oxymetazoline Hydrochloride0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7)  
Edetate Disodium (UNII: 7FLD91C86K)  
Glycerin (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 66715-6860-41 in 1 CARTON12/01/2014
130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/01/2014
Labeler - Lil' Drug Store Products, Inc (093103646)

Revised: 3/2018
 
Lil' Drug Store Products, Inc


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