OTC Medication Information: Little Remedies Decongestant Nasal Drops

LITTLE REMEDIES DECONGESTANT NASAL 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 REMEDIES DECONGESTANT NOSE DROPS- phenylephrine hydrochloride liquid
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Little Decongestant Drops

Drug Facts

Active ingredient

Phenylephrine Hydrochloride 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

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
  • do not use more than 3 days. Ues only as directed. Frequest or prolonged use may cause nasal congestion to revcur or worsen.

Stop use and ask a doctor if

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. Use only recommended amount.
  • Children under 2 years of age: Consult a doctor

Other information

  • 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?

1-800- 754-8853 Mon. – Fri. 8 am to 8 pm EST. www.LittleRemedies.com

PRINCIPAL DISPLAY PANEL

Little Remedies ®

DECONGESTANT NOSE DROPS
Phenylephrine H Cl / Nasal Decongestant
0.5 FL OZ (15 mL)

Little Remedies® 
DECONGESTANT NOSE DROPS
Phenylephrine HCl / Nasal Decongestant

0.5 FL OZ (15 mL)
(click image for full-size original)

LITTLE REMEDIES DECONGESTANT NASAL DROPS
phenylephrine hydrochloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-403
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
EDETATE DISODIUM ANHYDROUS
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
POTASSIUM PHOSPHATE, UNSPECIFIED FORM
WATER
SODIUM PHOSPHATE DIBASIC DIHYDRATE
Product Characteristics
Color WHITE (Clear) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63029-403-15 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (63029-403-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 01/01/2017
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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