# FDA API: Get drug label

> Finds the latest FDA drug label for a brand or generic medicine and returns its uses, directions, warnings, ingredients and a DailyMed link.

Unofficial. Not affiliated with or endorsed by FDA.

- Page: https://fous.com/methods/open.fda.gov/get-drug-label
- Method: `open.fda.gov/get_drug_label`, version 1
- Website: open.fda.gov
- Returns: brand and generic name, manufacturer, type, uses, directions, boxed warning, warnings, side effects, pregnancy information, effective date, DailyMed link
- Effect: read (it gets data and changes nothing)
- Sign-in: none needed
- Cost: 1 credit per completed run (1¢ with pay as you go); failed runs are free
- Verified: Nov 2, 2026

## Inputs

| Field | Type | Required | In the run below | Description |
|---|---|---|---|---|
| `medicine` | string | yes | `"sertraline"` | The brand or generic medicine name, for example Tylenol or sertraline. |

## Output

From a run on Oct 23, 2026, shortened. Its input:

```json
{
  "medicine": "sertraline"
}
```

Its output:

```json
{
  "type": "Prescription",
  "used_for": "1 INDICATIONS AND USAGE Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14) ] : Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenst…",
  "warnings": "5 WARNINGS AND PRECAUTIONS Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If it occurs, discontinue sertraline hydrochloride and serotonergic agents and initiate supportive treatment. ( 5.2 ) Increased Risk of Bleeding: Concomitant …",
  "brand_name": "Sertraline Hydrochloride",
  "how_to_take": "2 DOSAGE AND ADMINISTRATION ­Indication Starting Dosage Maximum Dosage MDD ( 2.1 ) 50 mg per day 200 mg per day OCD ( 2.1 ) 25 mg per day (ages 6-12) 50 mg per day (ages ≥ 13) 200 mg per day PD, PTSD, SAD ( 2.1 ) 25 mg per day 200 mg per day PMDD ( 2.2 ) continuous dosing 50 mg per day 150 mg per da…",
  "generic_name": "SERTRALINE HYDROCHLORIDE",
  "manufacturer": "REMEDYREPACK INC.",
  "boxed_warning": "WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors …",
  "dailymed_link": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7d598f1a-6c76-458a-a155-7a6a0743a2d3",
  "active_ingredients": "SERTRALINE HYDROCHLORIDE\n3 DOSAGE FORMS AND STRENGTHS Sertraline Hydrochloride Tablets USP, 25 mg Tablets: Light Green film coated Modified oval biconvex tablets debossed with I on the left Side of bisect and G on the right Side of bisect on one Side and “212” on other Tablets: 25 mg ( 3 )",
  "common_side_effects": "6 ADVERSE REACTIONS The following adverse reactions are described in more detail in other sections of the prescribing information: Hypersensitivity reactions to sertraline [See Contraindications (4) ] QTc prolongation and ventricular arrhythmias when taken with pimozide [See Contraindications (4) , …",
  "label_effective_date": "2026-09-03",
  "pregnancy_information": "8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers should encourage patients to enroll by calling the National Pregnancy Registry for Antidepressants at 1-866-961…"
}
```

## Run it

From code, with a Fous API key in `FOUS_API_KEY`; the answer's `data` holds the output:

```bash
curl https://api.fous.com/v1/runs \
  -H "Authorization: Bearer $FOUS_API_KEY" \
  -H "Content-Type: application/json" \
  -d '{"method":"open.fda.gov/get_drug_label","input":{"medicine":"sertraline"}}'
```

From an AI agent connected to the Fous MCP server: its `run` with the same method and input. To connect one, give it `set up https://fous.com/SKILL.md`.

## Ask your agent

- What are the uses, warnings and side effects listed on the latest label for sertraline?
- Show me the boxed warning and pregnancy information for Lipitor on fda.gov.
- I need the dosing directions and ingredients for Tylenol from its current drug label.
- Find the effective date and DailyMed link for the metformin label.
- Can you pull up the warnings and manufacturer details for amoxicillin?

## Input schema

```json
{
  "type": "object",
  "required": [
    "medicine"
  ],
  "properties": {
    "medicine": {
      "type": "string",
      "minLength": 1,
      "description": "The brand or generic medicine name, for example Tylenol or sertraline."
    }
  }
}
```

## Output schema

```json
{
  "type": "object",
  "required": [
    "brand_name",
    "generic_name",
    "manufacturer",
    "type",
    "used_for",
    "active_ingredients",
    "how_to_take",
    "boxed_warning",
    "warnings",
    "common_side_effects",
    "pregnancy_information",
    "label_effective_date",
    "dailymed_link"
  ],
  "properties": {
    "type": {
      "type": [
        "string",
        "null"
      ],
      "description": "Prescription or over the counter."
    },
    "used_for": {
      "type": [
        "string",
        "null"
      ],
      "description": "Uses and indications from the label."
    },
    "warnings": {
      "type": [
        "string",
        "null"
      ],
      "description": "Warnings or warnings and precautions from the label."
    },
    "brand_name": {
      "type": [
        "string",
        "null"
      ],
      "description": "Brand name on the selected label."
    },
    "how_to_take": {
      "type": [
        "string",
        "null"
      ],
      "description": "Directions or dosage and administration from the label."
    },
    "generic_name": {
      "type": [
        "string",
        "null"
      ],
      "description": "Generic name on the label."
    },
    "manufacturer": {
      "type": [
        "string",
        "null"
      ],
      "description": "Manufacturer or labeler listed by the FDA."
    },
    "boxed_warning": {
      "type": [
        "string",
        "null"
      ],
      "description": "Boxed warning, if any."
    },
    "dailymed_link": {
      "type": [
        "string",
        "null"
      ],
      "description": "Link to the label on DailyMed."
    },
    "active_ingredients": {
      "type": [
        "string",
        "null"
      ],
      "description": "Active ingredients and strengths from the label, when available."
    },
    "common_side_effects": {
      "type": [
        "string",
        "null"
      ],
      "description": "Adverse reactions or side effects listed on the label."
    },
    "label_effective_date": {
      "type": [
        "string",
        "null"
      ],
      "description": "Date this label became effective, in YYYY-MM-DD format."
    },
    "pregnancy_information": {
      "type": [
        "string",
        "null"
      ],
      "description": "Pregnancy information in the label."
    }
  }
}
```

## See more

- [FDA API: Search drug recalls](https://fous.com/methods/open.fda.gov/search-drug-recalls.md): Finds FDA drug enforcement recalls by medicine or company name, newest first, with status, class, reason and quantity. Recent recalls may not yet appear.
- [FDA API: Get reported side effects](https://fous.com/methods/open.fda.gov/get-reported-side-effects.md): Lists the most frequently reported reaction terms for a brand or generic medicine in FDA adverse-event reports, with counts and the share of all matching reports. Reports do not establish causation.
- [FDA API: Search food recalls](https://fous.com/methods/open.fda.gov/search-food-recalls.md): Finds FDA food recall enforcement reports by product, brand, or allergen, newest first. Reports are updated weekly and recall statuses may lag.
- [FDA API: Search medical device recalls](https://fous.com/methods/fda.gov/search-device-recalls.md): Finds FDA medical device recalls whose product description or recalling company matches a phrase, newest first, with the recall class and its health-risk meaning from each FDA recall page. An optional start date limits recalls to those initiated on or after it.
- [Drugs.com API: Get drug overview](https://fous.com/methods/drugs.com/get-drug.md): Looks up a medicine by brand or generic name on Drugs.com and returns a plain-language overview: class, uses, availability, schedule, dosage forms, side effects, and pregnancy and breastfeeding notes.
- [Drugs.com API: Get drug prices](https://fous.com/methods/drugs.com/get-drug-prices.md): Gets the US cash prices Drugs.com lists for a brand or generic medicine by strength, dosage form and quantity, optionally filtered. Where a range is listed the lower price is returned.
- [Drugs.com API: Identify pill by imprint](https://fous.com/methods/drugs.com/identify-pill.md): Finds possible pill matches on the Drugs.com pill identifier by imprint, optionally narrowed by color and shape, with each pill's labeler.
- [NHS API: Get medicine guidance](https://fous.com/methods/nhs.uk/get-medicine.md): Looks up a medicine in the NHS medicines A to Z and returns its guidance: uses, key facts, who can take it, how to take it, side effects, pregnancy and interactions. Sections absent from NHS guidance are null; a plain name with separate adult and child pages selects the adult page.
- [All FDA methods](https://fous.com/methods/fda.gov.md)