OTC Medication Information: Little Noses Decongestant Nose Drops

LITTLE NOSES DECONGESTANT NOSE DROPS- phenylephrine hydrochloride liquid
Medtech Products Inc.

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.

LITTLE NOSES DECONGESTANT NOSE DROPS- phenylephrine hydrochloride liquid
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Little Noses Decongestant Drops

Drug Facts

Active ingredient

Phenylephrine Hydrochloride USP 0.125%

Purpose

Nasal decongestant

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

Warnings

Do not exceed recommended dosage.

Do not use

with any other products containing decongestants.

Ask a doctor before use if the child has

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

When using this product

  • 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

  • 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.

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

Directions

(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

  • 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

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

Questions?

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

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)
(click image for full-size original)

LITTLE NOSES DECONGESTANT NOSE DROPS phenylephrine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-401
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 1.25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
POTASSIUM PHOSPHATE, UNSPECIFIED FORM
WATER
EDETIC ACID
SODIUM PHOSPHATE
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63029-401-01 1 BOTTLE, DROPPER in 1 BOX contains a BOTTLE, DROPPER
1 15 mL in 1 BOTTLE, DROPPER This package is contained within the BOX (63029-401-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 02/15/2011 12/31/2023
Labeler — Medtech Products Inc. (122715688)

Revised: 06/2020 Medtech Products Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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