Label: DISCOUNT DRUG MART SEVERE CONGESTION NASAL- oxymetazoline hydrochloride spray
- NDC Code(s): 53943-718-30
- Packager: DISCOUNT DRUG MART
- 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 August 31, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Ask a doctor before use if you have
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When using this product
- •
- do not use more than directed
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- do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
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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
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
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Directions
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- 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: ask a doctor
Shake well before use. Push down cap while turning counter-clockwise and remove cap. Remove clip under rim. Before using the first time, prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Replace clip under rim and secure cap after use.
- Other information
- Inactive ingredients
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Package/Label Principal Display Panel
DISCOUNT drug mart
FOOD FAIR
NDC# 53943-718-30
Compare to the Active Ingredient Afrin® No Drip Severe Congestion Pump Mist*
Maximum Strength
Severe Congestion Nasal Spray
OXYMETAZOLINE HCL 0.05%
NASAL DECONGESTANT
12 HOUR NO-DRIP
PUMP SPRAY
Plus Menthol
- •
- Fast and Powerful Congestion Relief
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- For Colds & Allergies
1 FL OZ (30mL)
Distributed by:
Discount Drug Mart
211 Commerce Drive
Medina, OH 44256
IMPORTANT: Keep this carton for future reference on full labeling.
SATISFACTION GUARANTEED: IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DIVE, MEDINA, OHIO 44256.
*This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Afrin® No Drip Severe Congestion Pump Mist.
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INGREDIENTS AND APPEARANCE
DISCOUNT DRUG MART SEVERE CONGESTION NASAL
oxymetazoline hydrochloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53943-718 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE .05 g in 100 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BENZYL ALCOHOL (UNII: LKG8494WBH) CAMPHOR (NATURAL) (UNII: N20HL7Q941) EDETATE DISODIUM (UNII: 7FLD91C86K) EUCALYPTOL (UNII: RV6J6604TK) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color WHITE (off white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53943-718-30 1 in 1 CARTON 05/22/2019 1 30 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 05/22/2019 Labeler - DISCOUNT DRUG MART (047741335)
