LITTLE REMEDIES DECONGESTANT NASAL DROPS- phenylephrine hydrochloride liquid

Little Remedies Decongestant Nasal Drops by

Drug Labeling and Warnings

Little Remedies Decongestant Nasal Drops by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 HCl / Nasal Decongestant

0.5 FL OZ (15 mL)

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)

Product Characteristics
Color	WHITE (Clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-403-15	1 in 1 CARTON	01/01/2017
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

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)