DailyMed - DOLLAR GENERAL- nasal phenylephrine hydrochloride spray (2024)

  • Label RSS
  • 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.

    DailyMed - DOLLAR GENERAL- nasal phenylephrine hydrochloride spray (2)

  • INGREDIENTS AND APPEARANCE
    DOLLAR GENERAL
    nasal phenylephrine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-827
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE1g in100mL
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorWHITEScore
    ShapeSize
    FlavorImprint Code
    Contains
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-827-301 in 1 CARTON05/20/2019
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/20/2019

    Labeler -DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)(068331990)

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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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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
DailyMed - DOLLAR GENERAL- nasal phenylephrine hydrochloride spray (2024)

FAQs

How much phenylephrine should I take for a stuffy nose? ›

Adults and children 12 years of age and older—Use two or three drops of a 0.25 to 0.5% solution in the nose every four hours as needed. Children 6 to 12 years of age—Use two or three drops of a 0.25% solution in the nose every four hours as needed.

How many days can you use phenylephrine nasal spray? ›

Nasal sprays containing either oxymetazoline or phenylephrine are the rebound congestion-inducing nasal sprays to use with caution. If a nasal spray contains either of these active ingredients, be sure to use only as directed on the label — three days or less.

What does phenylephrine nasal spray do? ›

Phenylephrine is used for the temporary relief of congestion or stuffiness in the nose caused by hay fever or other allergies, colds, or sinus trouble. It may also be used in ear infections to relieve congestion.

Does phenylephrine HCL help sinus pressure? ›

It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

What happens if you use too much phenylephrine nasal spray? ›

Symptoms of overdose may include: severe dizziness/fainting, hallucinations, fast/irregular heartbeat, slow/shallow breathing, vomiting, seizures.

Does phenylephrine actually work as a decongestant? ›

Researchers have conducted many more studies on the drug that have shown overwhelmingly that the oral formulation is clinically ineffective in reducing symptoms of congestion. The resulting advisory committee decision does not apply to nasal sprays, which are still thought to be effective.

Can you use too much nasal decongestant spray? ›

Rhinitis medicamentosa typically lasts for as long as you overuse nasal sprays. The more you continue to use nasal sprays, the worse your symptoms could get. Rhinitis medicamentosa is a type of nasal congestion resulting from overusing nasal sprays. It may cause an itchy, stuffy or runny nose.

How long does it take for phenylephrine hydrochloride to work? ›

Response and effectiveness

The decongestant effect of phenylephrine in cold or flu remedies should be noticeable within 15 to 30 minutes, and the effects last less than 4 hours. A rapid increase in blood pressure is usually seen following an intravenous dose that persists for up to 20 minutes.

When should you not use phenylephrine? ›

Warning and Precautions
  1. Phenylephrine use warrants caution in patients with a history of bradycardia, severe cardiac dysfunction, and hypovolemia.
  2. IV phenylephrine may worsen angina, heart failure, or pulmonary arterial hypertension in patients with severe arteriosclerosis or a history of angina.
Oct 30, 2023

Why is phenylephrine banned? ›

Since phenylephrine was included in the OTC decongestant monograph, they still sell OTC Sudafed and legitimately say, “We've got a decongestant in our product.” The problem is that there was a growing body of evidence that phenylephrine did not work as a decongestant when administered orally.

Can phenylephrine make congestion worse? ›

Rebound congestion develops when you use nasal sprays containing phenylephrine and oxymetazoline for too long. Rebound congestion is tough to treat and can take up to 1 year to go away. You can avoid rebound congestion by stopping decongestant nasal sprays after 3 to 5 days.

Does phenylephrine get rid of mucus? ›

The FDA and drug makers believed that constricting blood vessels that supply mucus glands in the nasal passages and sinuses would cause a drop in mucus production. However, new research shows that oral phenylephrine is no more effective than a placebo.

What nasal spray is best for sinus pressure? ›

Decongestants. These medicines help reduce the swelling in your nasal passages and ease the stuffiness and sinus pressure. They come as nasal sprays, like naphazoline (Privine), oxymetazoline (Afrin, Dristan, Nostrilla, Vicks Sinus Nasal Spray), or phenylephrine (Neo-Synephrine, Rhinall, Sinex).

Which is better for sinus congestion pseudoephedrine or phenylephrine? ›

Studies in 2006 and 2009 found pseudoephedrine to be more effective than phenylephrine in the treatment of nasal congestion.

What is a good substitute for phenylephrine? ›

Top alternatives to phenylephrine include pseudoephedrine (Sudafed), oxymetazoline (Afrin), and fluticasone propionate (Flonase). Saline rinses and sprays are effective, medication-free options to consider. Oral phenylephrine isn't dangerous to take if you have these products at home.

Is 10mg of phenylephrine a lot? ›

Typical dosing for Phenylephrine (Sudafed PE)

Age 12 years and up: The typical dose is 10 mg by mouth every 4 hours. Don't take more than 60 mg in a 24-hour period.

Can I take 2 phenylephrine HCl 10 mg? ›

adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: do not use this product for children under 12 years of ...

How long does 5mg phenylephrine last? ›

Following oral administration or topical application of phenylephrine to the mucosa, constriction of blood vessels in the nasal mucosa relieves nasal congestion associated with allergy or head colds. Following oral administration, nasal decongestion may occur within 15 or 20 minutes and may persist for up to 4 hours.

How long does it take phenylephrine to work? ›

Response and effectiveness

The decongestant effect of phenylephrine in cold or flu remedies should be noticeable within 15 to 30 minutes, and the effects last less than 4 hours. A rapid increase in blood pressure is usually seen following an intravenous dose that persists for up to 20 minutes.

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