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.

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Little Noses Decongestant Nose Drops

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)

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	1.25 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)
WATER (UNII: 059QF0KO0R)
EDETIC ACID (UNII: 9G34HU7RV0)
SODIUM PHOSPHATE (UNII: SE337SVY37)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63029-401-01	1 in 1 BOX	02/15/2011	12/31/2023
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	02/15/2011	12/31/2023

Labeler - Medtech Products Inc. (122715688)

Revised: 6/2020

Document Id: 783cf640-9987-4038-b165-6b9e80be41b8

Set id: 21760d0b-4e21-4684-93a4-a7bd068aa512

Version: 3

Effective Time: 20200630

Medtech Products Inc.