Little Noses Decongestant Nose Drops

Manufacturer
Medtech Products Inc.
Effective date
2020-06-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:24:04

Label at a glance#

ProductLittle Noses Decongestant Nose Drops
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves nasal congestion due to common cold, hay fever or other upper respiratory allergies helps clear nasal passages; shrinks swollen membranes temporarily restores freer breathing through the nose helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure

Dosage and administration

(nasal use only) Children 2 to under 6 years (with adult supervision): 2 to 3 drops in each nostril, not more often than every 4 hours Children under 2 years of age: Consult a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

LITTLE NOSES DECONGESTANT NOSE DROPS- phenylephrine hydrochloride liquid
----------

Little Noses Decongestant Drops

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine Hydrochloride USP 0.125%

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves nasal congestion due to common cold, hay fever or other upper respiratory allergies
  • helps clear nasal passages; shrinks swollen membranes
  • temporarily restores freer breathing through the nose
  • helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure

Warnings

WARNINGS SECTION

Do not exceed recommended dosage.

Do not use

OTC - DO NOT USE SECTION

with any other products containing decongestants.

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes

When using this product

OTC - WHEN USING SECTION

  • Temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur.
  • The use of this dispenser by more than one person may spread infection.
  • Use only as directed.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occurs
  • symptoms persist. Do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

(nasal use only)

  • Children 2 to under 6 years (with adult supervision): 2 to 3 drops in each nostril, not more often than every 4 hours
  • Children under 2 years of age: Consult a doctor

Other information

SPL UNCLASSIFIED SECTION

  • Do not use if plastic neck band on cap is broken or missing.
  • Do not use if solution is brown or contains a precipitate.
  • Protect from light.
  • Store at 20-25ºC (68-77ºF).
  • See bottle or box for lot number and expiration date.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzalkonium Chloride, Glycerin, Polyethylene Glycol, Potassium Phosphate Monobasic, Purified Water, Sodium EDTA, Sodium Phosphate Dibasic.

Questions?

OTC - QUESTIONS SECTION

For further information you may contact us at: 1-800-7-LITTLE Mon. – Fri. 8:00 a.m. to 8:00 p.m. EST. or visit us online at www.LittleRemedies.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MEDICATED FOR KIDS 2+
Little Noses® by Little Remedies®

DECONGESTANT NOSE DROPS

Phenylephrine Hydrochloride
GENTLE 1/8% FORMULA, NO ALCOHOL
½ FL. OZ. (15 mL)

MEDICATED FOR KIDS 2+ Little Noses® by Little Remedies® DECONGESTANT NOSE DROPS Phenylephrine Hydrochloride GENTLE 1/8% FORMULA, NO ALCOHOL ½ FL. OZ. (15 mL)MEDICATED FOR KIDS 2+ Little Noses® by Little Remedies® DECONGESTANT NOSE DROPS Phenylephrine Hydrochloride GENTLE 1/8% FORMULA, NO ALCOHOL ½ FL. OZ. (15 mL)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63029-401-012020-06-26C16284748780-19d75b9d0-d52e-f424-e053-dadaa90a57ceLittle Noses Decongestant Nose Drops
63029-401-012020-01-31C16284748780-19d75b9d0-d52e-f424-e053-dadaa90a57ceLittle Noses Decongestant Nose Drops

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W71
EDETIC ACIDINACTIVE INGREDIENT9G34HU7RV01
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1A1
POTASSIUM PHOSPHATEINACTIVE INGREDIENTB7862WZ6321
SODIUM PHOSPHATEINACTIVE INGREDIENTSE337SVY371
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63029-40163029-401-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 136 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / OPHTHALMIC2 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7LOTION / TOPICAL0.1 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37MOUTHWASH / BUCCALNAExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / AURICULAR (OTIC)0.02 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0SOLUTION / TOPICAL0.5 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR24.75 mgExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0SUPPOSITORY / RECTAL7 mgExact identifier — unii candidate
13 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7LIQUID / NASAL0.2 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37SUSPENSION / OPHTHALMIC0.2 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / AURICULAR (OTIC)0 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37SOLUTION / OPHTHALMIC0.81 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37INJECTION, SOLUTION / INTRAMUSCULAR0.14 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0SHAMPOO / TOPICAL0.2 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION / OPHTHALMIC1 mgExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0CREAM / TOPICAL0.5 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / TOPICAL0.01 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / NASAL40.46 mg/100mlExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / TOPICALNAExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37INJECTION / ORAL10.35 mgExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37INJECTION / INTRABURSALADJ PHExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SPRAY, METERED / NASAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SHAMPOO / TOPICAL0.2 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37SYRUP / ORAL1.5 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37SOLUTION / ORAL27 mg/5mlExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37INJECTION / INTRAMUSCULAR10.6 mgExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0INJECTION, SOLUTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37OINTMENT / TOPICAL0.15 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM PHOSPHATESODIUM PHOSPHATESE337SVY37INJECTION, SOLUTION / INTRAVENOUS0.14 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7OINTMENT / TOPICAL0.03 %w/wExact identifier — unii candidate
24 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
783cf640-9987-4038-b165-6b9e80be41b821760d0b-4e21-4684-93a4-a7bd068aa5122020-06-30WarningsExact identifier
spl id: 783cf640-9987-4038-b165-6b9e80be41b8
spl set id: 21760d0b-4e21-4684-93a4-a7bd068aa512

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.