Loratadine and pseudoephedrine sulfate
Claritin-D 12 Hour is an over-the-counter extended-release tablet containing loratadine (5 mg) and pseudoephedrine sulfate (120 mg). It relieves allergy symptoms like runny nose, sneezing, and itchy throat, plus nasal congestion. Take orally as directed. Manufactured by Bayer HealthCare LLC. This information was generated using AI and is provided for informational and research purposes only.
Complete Metadata
| @type | dcat:Dataset |
|---|---|
| accessLevel | public |
| accrualPeriodicity | R/P1Y |
| bureauCode |
[
"009:10"
]
|
| contactPoint |
{
"fn": "Division of Drug Information",
"@type": "vcard:Contact",
"hasEmail": "mailto:druginfo@fda.hhs.gov"
}
|
| description | Claritin-D 12 Hour is an over-the-counter extended-release tablet containing loratadine (5 mg) and pseudoephedrine sulfate (120 mg). It relieves allergy symptoms like runny nose, sneezing, and itchy throat, plus nasal congestion. Take orally as directed. Manufactured by Bayer HealthCare LLC. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Loratadine and pseudoephedrine sulfate",
"mediaType": "text/html",
"description": "
Access the FDA dataset for Loratadine and pseudoephedrine sulfate — ANDA 076050 submitted by Mylan Institutional LLC
",
"downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=076050"
}
]
|
| identifier | ANDA076050 |
| issued | 2016-09-16 |
| keyword |
[
"drug-manufacturers",
"drug-safety",
"health-care",
"medications",
"pharmaceuticals"
]
|
| landingPage | https://www.fda.gov/drugs |
| license | https://open.fda.gov/license |
| modified | 2025-03-17 |
| programCode |
[
"009:002"
]
|
| publisher |
{
"name": "U.S. Food and Drug Administration",
"@type": "org:Organization"
}
|
| theme |
[
"FDA"
]
|
| title | Loratadine and pseudoephedrine sulfate |