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

Why is phenylephrine still sold? ›

To fill the need for easily accessible cold medications, drug manufacturers switched to making their over-the-counter oral decongestants with phenylephrine, which the FDA had determined was safe and effective. The problem: phenylephrine isn't actually effective.

What is the brand name for phenylephrine hydrochloride spray? ›

Phenylephrine Nasal is available under the following different brand names: NeoSynephrine Nasal and Neo-Synephrine Cold & Sinus Mild Strength Spray.

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.

Is phenylephrine banned in the USA? ›

It's unanimous: FDA panel says decongestant drug phenylephrine does not work. For decades, hundreds of oral decongestant products containing phenylephrine have been available in the United States over the counter. But on Tuesday, an FDA advisory committee agreed by a 16-0 vote that the ingredient does not work.

Is phenylephrine being taken off the shelves? ›

U.S. pharmacy chain CVS Health said on Thursday it is pulling some of the most common decongestants with phenylephrine as the only active ingredient from its shelves and will no longer sell them. The move comes after a panel of advisers to U.S. health regulators raised doubts over the efficacy of the ingredient.

Is Afrin the same as phenylephrine? ›

How is Afrin® different from other decongestants like phenylephrine and pseudoephedrine? Decongestants in pill form like phenylephrine and pseudoephedrine can take longer to work. Afrin® works directly on nasal membranes, giving you nasal congestion relief instantly and lasts up to 12 hours.

What is the OTC name for phenylephrine? ›

Phenylephrine is a medication used in many cough and cold medicines. It's marketed as a decongestant. But an FDA advisory committee found no scientific evidence that it works at the currently approved oral dose. The brand name of this medication is Sudafed PE®.

Can you buy phenylephrine by itself? ›

You can walk into any pharmacy and buy phenylephrine off the shelf like you would for any other purchase. But for pseudoephedrine, there are special requirements.

Why avoid phenylephrine? ›

IV phenylephrine may worsen angina, heart failure, or pulmonary arterial hypertension in patients with severe arteriosclerosis or a history of angina.

What can you not mix with phenylephrine? ›

do not take phenylephrine if you are taking a monoamine oxidase (MAO) inhibitor, such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking one of these medications within the past 2 weeks.

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

Phenylephrine nasal may cause serious side effects. Stop using phenylephrine nasal and call your doctor at once if you have: severe sneezing, runny or stuffy nose, redness or swelling in your nose, or other worsening nasal symptoms (may be a sign of overuse of phenylephrine nasal);

Does Flonase have phenylephrine? ›

What are the active ingredients in FLONASE Headache & Allergy Relief. The active ingredients in FLONASE Headache & Allergy Relief are acetaminophen (325mg), chlorpheniramine (2mg), and phenylephrine HCI (5mg).

What happens if you use decongestant nasal spray for too long? ›

If you use a medicated decongestant nasal spray for more than 3 days in a row, you may develop rebound rhinitis medicamentosa (RM) when you do stop. This condition can cause prolonged sinus congestion. It may even damage your nasal passages over time.

What happened with phenylephrine? ›

The advisory committee discussed the new data and concluded that the data do not support the efficacy of oral phenylephrine at its currently recommended dose as an oral nasal decongestant.

Why has phenylephrine replaced pseudoephedrine? ›

A literature search was conducted in electronic databases and use of textbooks. Restrictions have been placed on the sale of PDE in the USA in an attempt to control the illicit production of methamphetamine. This has caused a switch from PDE to PE in many common cold and cough medicines.

Is phenylephrine worse than pseudoephedrine? ›

Pseudoephedrine has a greater incidence of central nervous system (CNS) stimulant effects than phenylephrine, such as insomnia. This is because it is more lipid-soluble and more likely to cross into the brain than phenylephrine because of its chemical structure.

Why can't you buy Sudafed anymore? ›

The Combat Methamphetamine Epidemic Act of 2005 has been incorporated into the Patriot Act signed by President Bush on March 9, 2006. The act bans over-the-counter sales of cold medicines that contain the ingredient pseudoephedrine, which is commonly used to make methamphetamine.

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