LITTLE REMEDIES DECONGESTANT NOSE DROPS- phenylephrine hydrochloride liquid

Little Remedies Decongestant Nose Drops by

Drug Labeling and Warnings

Little Remedies Decongestant Nose Drops by is a Otc medication manufactured, distributed, or labeled by Denison Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.
• Help clear nasal passages; shrink swollen membranes.
• Temporarily restores freer breathing through the nose.
• Help decongest sinus openings and passages.
• Temporarily releives 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.
  
• Do not use for more than 3 days
• Use only as directed.
• Frequent or prolonged use may cause nasal congestion to recur or worsen.

Stop use and ask a doctor if

• symptoms persist.

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 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, Disodium EDTA, Glycerin, Polyethylene Glycol, Potassium Phosphate Monobasic, Purified Water, 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 Remedies®

DECONGESTANT NOSE DROPS

Phenylephrine Hydrochloride

NO ALCOHOL

½ FL. OZ. (15 mL)

INGREDIENTS AND APPEARANCE

LITTLE REMEDIES DECONGESTANT NOSE DROPS 
phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-1217
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	0.00125 mg  in 1 mL

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

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-1217-02	1 in 1 BOX	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 - Denison Pharmaceuticals, Inc. (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, Inc.		001207208	manufacture(0295-1217)