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.

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Little Remedies Decongestant Nose Drops

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

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)

Other information

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)

Little Remedies® 
DECONGESTANT NOSE DROPS
Phenylephrine HCl / Nasal Decongestant

0.5 FL OZ (15 mL)

LITTLE REMEDIES DECONGESTANT NASAL DROPS 
phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-403
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE1.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (Clear) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-403-151 in 1 CARTON01/01/2017
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 - Medtech Products Inc. (122715688)

Revised: 6/2020
Document Id: f6c98986-25f6-4a8c-af11-1a80331adbe9
Set id: e8355eed-f1a2-4b4a-b65f-c2f4b28c12d1
Version: 1
Effective Time: 20200629
 
Medtech Products Inc.