ALPHAGAN P (Page 3 of 3)

16 HOW SUPPLIED/STORAGE AND HANDLING

ALPHAGAN ® P is supplied sterile, in teal opaque plastic LDPE bottles and tips, with purple high impact polystyrene (HIPS) caps as follows:

0.1%

5 mL in 10 mL bottle NDC 0023-9321-05

10 mL in 10 mL bottle NDC 0023-9321-10

15 mL in 15 mL bottle NDC 0023-9321-15

0.15%

5 mL in 10 mL bottle NDC 0023-9177-05

10 mL in 10 mL bottle NDC 0023-9177-10

15 mL in 15 mL bottle NDC 0023-9177-15

Storage: Store at 15o -25o C (59o -77o F).

17 PATIENT COUNSELING INFORMATION

Patients should be instructed that ocular solutions, if handled improperly or if the tip of the dispensing container contacts the eye or surrounding structures, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions (see WARNINGS AND PRECAUTIONS, 5.3). Always replace the cap after using. If solution changes color or becomes cloudy, do not use. Do not use the product after the expiration date marked on the bottle.

Patients also should be advised that if they have ocular surgery or develop an intercurrent ocular condition (e.g., trauma or infection), they should immediately seek their physician’s advice concerning the continued use of the present multidose container.

If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.

As with other similar medications, ALPHAGAN ® P may cause fatigue and/or drowsiness in some patients. Patients who engage in hazardous activities should be cautioned of the potential for a decrease in mental alertness.

© 2013 Allergan, Inc.

Irvine, CA 92612, U.S.A.

® marks owned by Allergan, Inc.

Patented. See: www.allergan.com/products/patent_notices

Made in the U.S.A.

Allergan Logo

71816US16

PRINCIPAL DISPLAY PANEL

ALLERGAN

NDC 0023-9321-10
Alphagan® P
(brimonidine tartrate
ophthalmic solution)
0.1%
10 mL
Rx only
sterile

PRINCIPAL DISPLAY PANEL
ALLERGAN
NDC  0023-9321-10
Alphagan® P
(brimonidine tartrate 
ophthalmic solution) 
0.1%
10 mL
Rx only 
sterile
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

ALLERGAN

NDC 0023-9177-10
Alphagan® P
(brimonidine tartrate
ophthalmic solution)
0.15%
10 mL
Rx only
sterile

PRINCIPAL DISPLAY PANEL
ALLERGAN
NDC  0023-9177-10
Alphagan® P
(brimonidine tartrate 
ophthalmic solution) 
0.15%
10 mL
Rx only 
sterile
(click image for full-size original)
ALPHAGAN P
brimonidine tartrate solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0023-9321
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BRIMONIDINE TARTRATE (BRIMONIDINE) BRIMONIDINE TARTRATE 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BORIC ACID
CALCIUM CHLORIDE
MAGNESIUM CHLORIDE
POTASSIUM CHLORIDE
WATER
SODIUM BORATE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
SODIUM CHLORIDE
HYDROCHLORIC ACID
SODIUM HYDROXIDE
SODIUM CHLORITE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0023-9321-03 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 3 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (0023-9321-03)
2 NDC:0023-9321-05 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
2 5 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (0023-9321-05)
3 NDC:0023-9321-10 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
3 10 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (0023-9321-10)
4 NDC:0023-9321-15 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
4 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (0023-9321-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021770 01/25/2006
ALPHAGAN P
brimonidine tartrate solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0023-9177
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BRIMONIDINE TARTRATE (BRIMONIDINE) BRIMONIDINE TARTRATE 1.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BORIC ACID
CALCIUM CHLORIDE
MAGNESIUM CHLORIDE
POTASSIUM CHLORIDE
WATER
SODIUM BORATE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
SODIUM CHLORIDE
HYDROCHLORIC ACID
SODIUM HYDROXIDE
SODIUM CHLORITE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0023-9177-05 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 5 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (0023-9177-05)
2 NDC:0023-9177-10 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
2 10 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (0023-9177-10)
3 NDC:0023-9177-15 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
3 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (0023-9177-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021262 07/10/2001
Labeler — Allergan, Inc. (144796497)

Revised: 09/2013 Allergan, Inc.

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