Label: OPCON-A- naphazoline hydrochloride and pheniramine maleate solution/ drops
- NDC Code(s): 24208-430-03, 24208-430-15, 24208-430-30, 24208-430-45
- Packager: Bausch & Lomb Incorporated
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 14, 2023
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- Active ingredients
- Purposes
- Uses
-
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
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- heart disease
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- high blood pressure
- •
- trouble urinating due to an enlarged prostate gland
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- narrow angle glaucoma
When using this product
- •
- overuse may cause more eye redness
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- pupils may become enlarged temporarily
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- do not touch tip of container to any surface to avoid contamination
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- you may feel a brief tingling after putting drops in eye
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- replace cap after use
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- remove contact lenses before using
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Package/Label Principal Display Panel
TWIN PACK
NDC 24208-430-45
BAUSCH + LOMB
Opcon-A®
pheniramine maleate 0.315% and naphazoline
hydrochloride 0.02675% ophthalmic solution
ANTIHISTAMINE AND REDNESS RELIEVER
EYE DROPS
CLINICALLY PROVEN
EYE ALLERGY RELIEFitching + redness
caused by pollen, ragweed, grass, animal hair and dander
[teardrop icon]
STERILE
2 x 15 mL BOTTLES
(0.5 FL OZ EACH)3844801
AB55299 -
INGREDIENTS AND APPEARANCE
OPCON-A
naphazoline hydrochloride and pheniramine maleate solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24208-430 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BORIC ACID (UNII: R57ZHV85D4) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) SODIUM BORATE (UNII: 91MBZ8H3QO) SODIUM CHLORIDE (UNII: 451W47IQ8X) HYDROCHLORIC ACID (UNII: QTT17582CB) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24208-430-03 1 in 1 CARTON 08/06/1994 04/01/2013 1 3 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 2 NDC:24208-430-15 1 in 1 CARTON 08/06/1994 2 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 3 NDC:24208-430-30 1 in 1 CARTON 08/06/1994 07/01/2011 3 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 4 NDC:24208-430-45 2 in 1 CARTON 07/01/2015 4 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020065 06/08/1994 Labeler - Bausch & Lomb Incorporated (196603781) Establishment Name Address ID/FEI Business Operations Bausch & Lomb Incorporated 079587625 MANUFACTURE(24208-430)