MECLIZINE HYDROCHLORIDE
Generic: MECLIZINE
Basic Information
Manufacturer
A-S Medication Solutions
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
949f7347-8c3a-43ce-b975-8d187096f09f
Indications & Usage
1 INDICATIONS AND USAGE Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults.
Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults ( 1 ).
Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults ( 1 ).
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions associated with the use of meclizine hydrochloride were identified in clinical studies or postmarketing reports.
Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, and vomiting.
On rare occasions blurred vision has been reported.
Common adverse reactions are anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, and vomiting.
On rare occasions blurred vision has been reported ( 6 ).
To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc.
at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, and vomiting.
On rare occasions blurred vision has been reported.
Common adverse reactions are anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, and vomiting.
On rare occasions blurred vision has been reported ( 6 ).
To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc.
at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.