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- NDC Code(s): 55910-827-30
- Packager: DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)
- 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 September 15, 2023
If you are a consumer or patient please visit this version.
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- Active ingredient
Phenylephrine hydrochloride 1%
- Purpose
Nasal decongestant
- Uses
for the temporary relief of 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 exceed recommended dosage
- ▪
- do not use for more than 3 days. Use only as directed.
- ▪
- temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
- ▪
- the use of this container by more than one person may spread infection
- ▪
- frequent or prolonged use may cause nasal congestion to recur or worsen
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 right away at 1-800-222-1222.
- Directions
- ▪
- adults and children 12 years of age & older: 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
- ▪
- store at room temperature
- ▪
- container is filled to proper level for best spray action
- Inactive ingredients
benzalkonium chloride, benzyl alcohol, citric acid, purified water, sodium chloride, sodium citrate
- Principal Display Panel
NDC 55910-827-30
Since 1903
Rexall®
Nasal Spray
Nasal Decongestant
Phenylephrine Hydrochloride 1 %
Fast Acting Relief of:
- •
- Nasal congestion
- •
- Sinus congestion
- •
- Sinus pressure
- •
- Swollen nasal membranes
1 FL OZ (30mL)
DO NOT USE IF PRINTED SEAL OVER CAP IS TORN OR MISSING
Visit us at: Rexall.com
PACKAGED FOR DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072 USA
IMPORTANT: Keep this carton for future reference on full labeling.
- INGREDIENTS AND APPEARANCE
DOLLAR GENERAL
nasal phenylephrine hydrochloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-827 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 1g in100mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BENZYL ALCOHOL (UNII: LKG8494WBH) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-827-30 1 in 1 CARTON 05/20/2019 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 05/20/2019 Labeler -DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)(068331990)
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Safety
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Related Resources
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More Info on this Drug
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View Labeling Archives for this drug
DOLLAR GENERAL- nasal phenylephrine hydrochloride spray
Number of versions: 5
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Sep 18, 2023 | 5 (current) | download |
| Jul 6, 2022 | 4 | download |
| Aug 12, 2021 | 3 | download |
| Aug 14, 2020 | 2 | download |
| Jul 18, 2019 | 1 | download |
RxNorm
DOLLAR GENERAL- nasal phenylephrine hydrochloride spray
| RxCUI | RxNorm NAME | RxTTY | |
|---|---|---|---|
| 1 | 1087043 | phenylephrine HCl 1 % Nasal Spray | PSN |
| 2 | 1087043 | phenylephrine hydrochloride 10 MG/ML Nasal Spray | SCD |
| 3 | 1087043 | phenylephrine hydrochloride 1 % Nasal Spray | SY |
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DOLLAR GENERAL- nasal phenylephrine hydrochloride spray
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NDC Codes
DOLLAR GENERAL- nasal phenylephrine hydrochloride spray
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 55910-827-30 |
