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Nitrolingual (Nitroglycerin): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
400 mcg
Drug class:
Active ingredient:

Patient information: uses, side effects, how to take - Nitrolingual

Instructions for Use

Nitrolingual® Pumpspray ( nī-trō-ling´gwal)

(nitroglycerin )

lingual spray

Read this Instructions for Use before you start using Nitrolingual Pumpspray and each time you get your prescription refilled. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Important information:

  • Nitrolingual Pumpspray is for use on to or under the tongue. Do not inhale Nitrolingual Pumpspray.
  • A dose of Nitrolingual Pumpspray may be either 1 or 2 sprays. Follow your healthcare provider’s instructions about how many sprays you should use for each dose. Doses should be separated by approximately 5 minutes.
  • You should not use more than 3 sprays of Nitrolingual Pumpspray within 15 minutes.
  • Get emergency medical help right away if you still have chest pain after using a total of 3 sprays of Nitrolingual Pumpspray.

Nitrolingual Pumpspray parts:

Figure A

How should I use Nitrolingual Pumpspray ?

  • It is best to use Nitrolingual Pumpspray while you are resting and in a sitting position.
  • Do not shake the Nitrolingual Pumpspray container.

Priming Nitrolingual Pumpspray :

Before you use Nitrolingual Pumpspray for the first time, you must prime it. To prime your Nitrolingual Pumpspray, follow the steps below:

Step 1. Remove the plastic cap from the container. (See Figure B)

Figure B

Step 2. Hold the container upright and facing away from yourself and others. Press down on the top of the grooved button 5 times. (See Figure C)

Figure C

  • Your Nitrolingual Pumpspray is now primed. You are ready to give your first dose.
  • If you do not use your Nitrolingual Pumpspray within 6 weeks, you will need to prime it again by pressing down on the top of the grooved button 1 time.
  • If you do not use your Nitrolingual Pumpspray within 3 months, you will need to re-prime it by pressing down on the top of the grooved button up to 5 times.

Giving a dose of Nitrol i ngual Pumpspray :

Step 3. Hold your Nitrolingual Pumpspray container upright with your index finger on top of the grooved button.

Step 4. Open your mouth and bring the Nitrolingual Pumpspray container as close to your mouth as possible.

Step 5. Press down on the top of the grooved button firmly with your index finger to release the spray onto or under your tongue. (See Figure D). The grooved button can help you make sure the canister is turned to the correct position if you are administering the spray in the dark.

Figure D

Step 6. Release the grooved button and close your mouth right away. Avoid swallowing right after using Nitrolingual Pumpspray. Do not spit out Nitrolingual Pumpspray or rinse your mouth for 5 to 10 minutes after using Nitrolingual Pumpspray.

Step 7. If a second dose of Nitrolingual Pumpspray is needed, repeat Steps 3 through 6 above.

Step 8. Replace the plastic cap.

Check the level of the fluid in your Nitrolingual Pumpspray container regularly.

  • Check the container in an upright position.
  • The end of the center tube should be covered by the fluid in the Nitrolingual Pumpspray container. If the level of the fluid falls below the end of the center tube, sprays will not provide enough Nitrolingual Pumpspray.
  • Replace your Nitrolingual Pumpspray container before the fluid level falls below the end of the center tube.

How should I store Nitrolingual Pumpspray?

  • Store Nitrolingual Pumpspray at room temperature between 68°F - 77°F (20°C - 25°C).
  • Do not forcefully open or burn the Nitrolingual Pumpspray container after use.
  • Do not spray Nitrolingual Pumpspray toward flames.

Keep Nitrolingual Pumpspray and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured for:

Independence Pharmaceuticals, LLC

Mason, OH 45040 USA

by G. Pohl-Boskamp GmbH & Co. KG,

25551 Hohenlockstedt, Germany.

Revised: 05/2024

The following trademarks are either registered trademarks or trademarks of Pohl-Boskamp in the United States and / or other countries:

Pohl-Boskamp word mark; Pohl-Boskamp logo; Nitrolingual® word mark; Nitrolingual® Pumpspray shapes, Nitrolingual® Pumpspray colors.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 018705 · View the label on DailyMed

Revision date stated in the text: May 2024

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Nitrolingual

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Nitrate Vasodilator
Active ingredient Nitroglycerin 400 mcg
Dosage form Spray
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) POHL BOSKAMP
FDA approval NDA 018705New Drug Application (NDA) Approved October 31, 1985
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
400 mcg – 60 in 1 bottle, spray / 1 in 1 carton NDC 21724-100-50
400 mcg – 200 in 1 bottle, spray / 1 in 1 carton NDC 21724-100-41

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.