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NDC 49035-0430-15 Eye Allergy Relief .2675; 3.15 mg/mL; mg/mL Details

Eye Allergy Relief .2675; 3.15 mg/mL; mg/mL

Eye Allergy Relief is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores Inc. The primary component is NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE.

Product Information

NDC	49035-0430
Product ID	49035-430_e3cef1db-322d-45e0-b39f-442af74ee5b7
Associated GPIs	86409902142015
GCN Sequence Number	051262
GCN Sequence Number Description	naphazoline HCl/pheniramine DROPS .0268-.315 OPHTHALMIC
HIC3	Q2H
HIC3 Description	EYE ANTIHISTAMINE-VASOCONSTRICTOR COMBINATIONS
GCN	18447
HICL Sequence Number	003407
HICL Sequence Number Description	NAPHAZOLINE HCL/PHENIRAMINE MALEATE
Brand/Generic	Generic
Proprietary Name	Eye Allergy Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Pheniramine Maleate and Naphazoline Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	OPHTHALMIC
Active Ingredient Strength	.2675; 3.15
Active Ingredient Units	mg/mL; mg/mL
Substance Name	NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
Labeler Name	Wal-Mart Stores Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA020065
Listing Certified Through	2024-12-31

Package

Package Images

NDC 49035-0430-15 (49035043015)

Pricing Information	N/A
NDC Package Code	49035-430-15
Billing NDC	49035043015
Package	1 BOTTLE, DROPPER in 1 CARTON (49035-430-15) / 15 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2010-08-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 873a072f-159b-44b8-aad8-33963d961afb Details

Active ingredients

Naphazoline HCl (0.02675%)

Pheniramine maleate (0.315%)

Purpose

Redness reliever

Antihistamine

Uses

•: temporarily relieves itching and redness caused by pollen, ragweed, grass, animal hair and dander.

Warnings

For external use only

Do not use

•: if you are sensitive to any ingredient in this product
•: if solution changes color or becomes cloudy

Ask a doctor before use if you have

•: heart disease
•: high blood pressure
•: trouble urinating due to an enlarged prostate gland
•: narrow angle glaucoma

When using this product

•: overuse may cause more eye redness
•: pupils may become enlarged temporarily
•: do not touch tip of container to any surface to avoid contamination
•: you may feel a brief tingling after putting drops in eye
•: replace cap after use
•: remove contact lenses before using

Stop use and ask a doctor if you experience

•: eye pain
•: changes in vision
•: redness or irritation of the eye that worsens or lasts more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. Accidental oral ingestion in infants and children may lead to coma and marked reduction in body temperature.

Directions

•: Adults and children 6 years of age and older: Instill 1 or 2 drops in the affected eye(s) up to 4 times daily
•: Children under 6 years: ask a doctor

Other information

•: store at 20°-25° C (68°-77° F)
•: this package is child-resistant
•: protect from light
•: use before expiration date marked on the carton or bottle

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, hypromellose, purified water, sodium borate, sodium chloride. Hydrochloric acid may be used to adjust pH.

Questions?

Call:1-888-287-1915

Package/Label Principal Display Panel

NDC 49035-430-15

equate™

Compare to Opcon-A active ingredient

Eye Allergy

Relief Drops

Pheniramine Maleate 0.315%

and Naphazoline

Hydrochloride

0.02675%

Ophthalmic Solution

Itching and Redness

Reliever Eye Drops

Sterile

0.5 FL OZ (15mL)

INGREDIENTS AND APPEARANCE

EYE ALLERGY RELIEF

pheniramine maleate and naphazoline hydrochloride solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-430
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV)	NAPHAZOLINE HYDROCHLORIDE	0.2675 mg in 1 mL
PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M)	PHENIRAMINE MALEATE	3.15 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE SODIUM (UNII: MP1J8420LU)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROCHLORIC ACID (UNII: QTT17582CB)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-430-15	1 in 1 CARTON	08/31/2010
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC:49035-430-30	2 in 1 CARTON	08/31/2010	09/01/2019
2		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA020065	08/31/2010

Labeler - Wal-Mart Stores Inc (051957769)

Registrant - Bausch & Lomb Incorporated (196603781)

Name	Address	ID/FEI	Business Operations
Establishment
Bausch & Lomb Incorporated		079587625	MANUFACTURE(49035-430)

Revised: 4/2021

Document Id: e3cef1db-322d-45e0-b39f-442af74ee5b7

Set id: 873a072f-159b-44b8-aad8-33963d961afb

Version: 7

Effective Time: 20210405