NASAL DECONGESTANT RHINALL- phenylephrine hydrochloride 0.25 spray 
Product Quest Mfg.

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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Frug Facts

​Active ingredient                     Purpose

Phenylephrine HCl 0.25%........Nasal decongestan

Uses


Temporarly relieves nasal congestion due to • common cold • hay fever or other respiratory allergies associated with sinusitis • stuffy nose
Helps clear nasal passages; shrinks swollen membranes.
Temporarily restores freer breathing through the nose.
Helps decongest sinus openings and passages; temporarily relieves sinus congestion.

Warnings

Do not exceed recommended dosage


Ask a doctor before use if you have: • heart disease • high blood pressure • diabetes• thyroid disease • difficulty in urination due to enlargement of the prostate gland

When using this product temporary discomfort may occur such as: • burning • stinging • sneezing • increase in nasal discharge • Use by more than one person may spread infection


Stop use and ask doctor if 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.
If pregnant or breastfeeding, ask a health care professional before use.

KEEP OUT OF THE REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 12 years of age and over: 2 or 3 drops in each nostril not more often than every 4 hours. Children under 12 years of age: ask a doctor.

Inactive ingredients


Benzalkonium Chloride, Chlorobutanol Hemihydrate, Disodium EDTA, Polysorbate, Sodium Bisulfite, Sodium Chloride, Sorbitol, Water.

image description

NASAL DECONGESTANT  RHINALL
phenylephrine hydrochloride 0.25 spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64048-5000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE0.25 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
CHLOROBUTANOL HEMIHYDRATE (UNII: 3X4P6271OX)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM BISULFITE (UNII: TZX5469Z6I)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64048-5000-11 in 1 CARTON01/15/2010
140 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/15/2010
Labeler - Product Quest Mfg. (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg.927768135manufacture(64048-5000) , label(64048-5000)

Revised: 3/2018
Document Id: 6ab3071a-e8ba-46b0-aec2-16ef059406de
Set id: 16c1b9f4-23da-43d2-a7b6-b0851370b4bb
Version: 2
Effective Time: 20180329
 
Product Quest Mfg.