Label: NASAL DECONGESTANT RHINALL- phenylephrine hydrochloride 0.25 spray
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Contains inactivated NDC Code(s)
NDC Code(s): 64048-5000-1 - Packager: Product Quest Mfg.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated March 29, 2018
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
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 glandWhen 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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NASAL DECONGESTANT RHINALL
phenylephrine hydrochloride 0.25 sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64048-5000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 0.25 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:64048-5000-1 1 in 1 CARTON 01/15/2010 1 40 mL in 1 TUBE; 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 01/15/2010 Labeler - Product Quest Mfg. (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg. 927768135 manufacture(64048-5000) , label(64048-5000)
