NAPHAZOLINE HCI AND PHENIRAMINE MALEATE- naphazoline hydrochloride , pheniramine maleate solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV), PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M)

Available from:

Altaire Pharmaceuticals Inc.

INN (International Name):

NAPHAZOLINE HYDROCHLORIDE

Composition:

NAPHAZOLINE HYDROCHLORIDE 0.027 mL in 100 mL

Administration route:

OPHTHALMIC

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Redness Reliever Antihistamine Uses: temporarily relieves itching and redness caused by pollen, ragweed, grass, animal hair and dander. Do not use if imprinted seal on cap is torn, broken or missing, or if imprinted seals on top ad bottom flaps are not intact and completely legible. Stop use and ask a doctor if you experience: eye pain, changes in vision, redness or irritation of the eye that worsens or persists for more than 72 hours. Overuse of this product may produce increased redness of the eye. Pupils may become enlarged temporarily. You may experience a brief tingling sensation after putting drops in eyes.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NAPHAZOLINE HCI AND PHENIRAMINE MALEATE- NAPHAZOLINE HYDROCHLORIDE ,
PHENIRAMINE MALEATE SOLUTION/ DROPS
ALTAIRE PHARMACEUTICALS INC.
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NAPHAZOLINE HCI 0.027% & PHENIRAMINE MALEATE 0.315% OPHTHALMIC
SOLUTION, USP
Active Ingredients
Naphazoline Hydrochloride (0.027%)
Pheniramine Maleate (0.315%)
Purpose
Redness Reliever
Antihistamine
Uses: temporarily relieves itching and redness caused by pollen,
ragweed, grass, animal hair and
dander.
Warnings: if you experience eye pain, changes in vision, continued
redness or irritation of the eye, or if
the condition worsens or persists for more than 72 hours, discontinue
use and consult a physician. Do
not use in children under 6 years of age unless directed by a
physician. If this solution changes color or
becomes cloudy, do not use. Overuse of this product may produce
increased redness of the eye.
If you are sensitive to any ingredient in this product, do not use. To
avoid contamination, do not touch tip
of container to any surface. Replace cap after using.
Do not use if imprinted seal on cap is torn, broken or missing, or if
imprinted seals on top ad bottom
flaps are not intact and completely legible.
Ask a doctor before use if you have
heart disease
high blood pressure
trouble urinating due to enlarged prostrate gland
narrow angle glaucoma
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 persists for more than 72 hours. Overuse of this
product may produce increased
redness of the eye. Pupils may become enlarged temporarily. You may
experience a brief tingling
sensation after putting drops in eyes.
Keep out of reach of children.
In case of accidental ingestion, seek professional assistance or
contact a Poison Control Center
immediately. 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
affected eye(s) up to 4 times d