DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Olopatadine (1 mg)

Inactive Ingredients

Benzalkonium Chloride Sodium Phosphate, Dibasic Hydrochloric Acid Sodium Hydroxide Sodium Chloride Water

Identifiers & Packaging

Marketing Status

ANDA Active Since 2021-02-18

Medication Information

Purpose

Antihistamine and redness reliever

Description

Olopatadine (0.1%).........(equivalent to olopatadine hydrochloride 0.111%)

Use(s)

temporarily relieves itchy red eyes due to pollen, ragweed, grass, animal hair and dander

Warnings

For external use only

Directions

• adults and children 2 years of age and older:

      • put 1 drop in the affected eye(s) twice daily, every 6 to 8 hours, no more than twice per day

      • if using other ophthalmic products while using this product, wait at least 5 minutes between each product

      • replace cap after each use

• children under 2 years of age: consult a doctor

Do Not Use

• if solution changes color or becomes cloudy

• if you are sensitive to any ingredient in this product

• to treat contact lens related irritation

Questions?

Contact Alembic Pharmaceuticals Inc. at 1-866-210-9797

Other Information

• only for use in the eye

• store between 4°C to 25°C (39°F to 77°F)

Active Ingredient(s)

Olopatadine (0.1%).........(equivalent to olopatadine hydrochloride 0.111%)

Inactive Ingredients

benzalkonium chloride 0.01%, dibasic sodium phosphate, hydrochloric acid/sodium hydroxide (adjust pH), sodium chloride, and water for Injection

Principal Display Panel

Olopatadine Hydrochloride Ophthalmic Solution 0.1%-Bottle Label: Alembic

Olopatadine Hydrochloride Ophthalmic Solution 0.1%- Carton Label: Alembic

When Using This Product

• do not touch tip of container to any surface to avoid contamination

• remove contact lenses before use

• wait at least 10 minutes before reinserting contact lenses after use

• do not wear a contact lens if your eye is red

Stop Use and Ask Doctor If

you experience:

eye pain
changes in vision
increased redness of the eye
itching worsens or lasts for more than 72 hours

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Use(s) (USE(S))

temporarily relieves itchy red eyes due to pollen, ragweed, grass, animal hair and dander

Purpose (PURPOSE)

Antihistamine and redness reliever

Warnings (WARNINGS)

For external use only

Directions (DIRECTIONS)

• adults and children 2 years of age and older:

      • put 1 drop in the affected eye(s) twice daily, every 6 to 8 hours, no more than twice per day

      • if using other ophthalmic products while using this product, wait at least 5 minutes between each product

      • replace cap after each use

• children under 2 years of age: consult a doctor

Do Not Use (DO NOT USE)

• if solution changes color or becomes cloudy

• if you are sensitive to any ingredient in this product

• to treat contact lens related irritation

Questions? (QUESTIONS?)

Contact Alembic Pharmaceuticals Inc. at 1-866-210-9797

Other Information (OTHER INFORMATION)

• only for use in the eye

• store between 4°C to 25°C (39°F to 77°F)

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Olopatadine (0.1%).........(equivalent to olopatadine hydrochloride 0.111%)

Inactive Ingredients (INACTIVE INGREDIENTS)

benzalkonium chloride 0.01%, dibasic sodium phosphate, hydrochloric acid/sodium hydroxide (adjust pH), sodium chloride, and water for Injection

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Olopatadine Hydrochloride Ophthalmic Solution 0.1%-Bottle Label: Alembic

Olopatadine Hydrochloride Ophthalmic Solution 0.1%- Carton Label: Alembic

When Using This Product (WHEN USING THIS PRODUCT)

• do not touch tip of container to any surface to avoid contamination

• remove contact lenses before use

• wait at least 10 minutes before reinserting contact lenses after use

• do not wear a contact lens if your eye is red

Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)

you experience:

eye pain
changes in vision
increased redness of the eye
itching worsens or lasts for more than 72 hours

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "OLOPATADINE", "unii": "D27V6190PM", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC", "unii": "GR686LBA74", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROCHLORIC ACID", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USE(S)": "temporarily relieves itchy red eyes due to pollen, ragweed, grass, animal hair and dander", "PURPOSE": "Antihistamine and redness reliever", "WARNINGS": "For external use only", "DIRECTIONS": "• adults and children 2 years of age and older: • put 1 drop in the affected eye(s) twice daily, every 6 to 8 hours, no more than twice per day • if using other ophthalmic products while using this product, wait at least 5 minutes between each product • replace cap after each use • children under 2 years of age : consult a doctor", "DO NOT USE": "• if solution changes color or becomes cloudy • if you are sensitive to any ingredient in this product • to treat contact lens related irritation", "QUESTIONS?": "Contact Alembic Pharmaceuticals Inc. at 1-866-210-9797", "OTHER INFORMATION": "• only for use in the eye • store between 4°C to 25°C (39°F to 77°F)", "ACTIVE INGREDIENT(S)": "Olopatadine (0.1%).........(equivalent to olopatadine hydrochloride 0.111%)", "INACTIVE INGREDIENTS": "benzalkonium chloride 0.01%, dibasic sodium phosphate, hydrochloric acid/sodium hydroxide (adjust pH), sodium chloride, and water for Injection", "PRINCIPAL DISPLAY PANEL": "Olopatadine Hydrochloride Ophthalmic Solution 0.1%-Bottle Label: Alembic Olopatadine Hydrochloride Ophthalmic Solution 0.1%- Carton Label: Alembic", "WHEN USING THIS PRODUCT": "• do not touch tip of container to any surface to avoid contamination • remove contact lenses before use • wait at least 10 minutes before reinserting contact lenses after use • do not wear a contact lens if your eye is red", "STOP USE AND ASK DOCTOR IF": "you experience: eye pain changes in vision increased redness of the eye itching worsens or lasts for more than 72 hours", "KEEP OUT OF REACH OF CHILDREN": "If swallowed, get medical help or contact a Poison Control Center right away."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information