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LITTLE NOSES DECONGESTANT NOSE DROPS (phenylephrine hydrochloride) liquid
[Medtech Products Inc.]


NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKEDTED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

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)

PRINCIPAL DISPLAY PANEL
Little Noses® by Little Remedies®
DECONGESTANT NOSE DROPS
Phenylephrine Hydrochloride
½ FL. OZ. (15 mL)

INGREDIENTS & APPEARANCE

LITTLE NOSES DECONGESTANT NOSE DROPS 
phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63029-401
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE0.00125 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
GLYCERIN 
POLYETHYLENE GLYCOL 
POTASSIUM PHOSPHATE 
WATER 
EDETIC ACID 
SODIUM PHOSPHATE 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-401-011 in 1 BOX
115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34102/15/2011
Labeler - Medtech Products Inc. (122715688)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, Inc.001207208MANUFACTURE

Revised: 2/2011
 
Medtech Products Inc.