LITTLE REMEDIES DECONGESTANT NOSE DROPS- phenylephrine hydrochloride liquid 
Denison Pharmaceuticals, 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 Remedies Decongestant Drops

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)

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

LITTLE REMEDIES DECONGESTANT NOSE DROPS 
phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-1217
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.00125 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-1217-021 in 1 BOX01/01/2017
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2017
Labeler - Denison Pharmaceuticals, Inc. (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, Inc.001207208manufacture(0295-1217)

Revised: 1/2019
Document Id: 7fa9cf7b-a160-9c4a-e053-2991aa0a0a9d
Set id: e8d8f870-b297-44d0-9555-5130ff816b7f
Version: 2
Effective Time: 20190117
 
Denison Pharmaceuticals, Inc.