NDC | 63868-080-01 |
Set ID | b5aa76eb-acc8-495f-85c9-bfdbb2d80e2a |
Category | HUMAN OTC DRUG LABEL |
Packager | QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART341 |
- Active ingredient
- Purpose
- Uses
- Warnings
- Ask a doctor before use if you have
-
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
- If pregnant or breast-feeding,
- Keep out of reach of children.
-
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: ask a doctor
To Use: 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 rim 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
-
Package/Label Principal Display Panel
QUALITY CHOICE®
NDC# 63868-080-01
*Compare to Active Ingredient Afrin® No Drip Severe Congestion
12 hour relief
Nasal Mist No Drip
Severe Congestion
Oxymetazoline HCl 0.05%
Nasal Solution
Fast and Powerful Congestion Relief
For Colds & Allergies
No Drip Pump Mist Won’t Drip from Nose or Down Throat
Maximum Strength
Plus Menthol
Unique Formula with Menthol
1 FL OZ (30mL)
100% QC SATISFACTION GURANTEED
Distributed by C.D.M.A., Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995
Questions: 800-935-2362
*This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Afrin® No Drip Severe Congestion.
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INGREDIENTS AND APPEARANCE
QUALITY CHOICE NASAL MAXIMUM STRENGTH
oxymetazoline hydrochloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-080 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 FORM (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 MENTHOL Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-080-01 1 in 1 CARTON 04/16/2019 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 04/16/2019 Labeler - QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) (011920774)