Nitro-Time
2.5 mg · Capsule
- Prescription only
- Nitrate Vasodilator
- Active substance
- Nitroglycerin
- Made by
- TIME CAP LABORATORIES, INC
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2026-05-18
Nitrate Vasodilator
- Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product…
In clinical trials, the initial regimen of nitroglycerin has been 2.5 to 6.5 mg three to four times a day, with subsequent upward dose adjustment guided by symptoms and side effects.
Full directions ↓Allergic reactions to organic nitrates are extremely rare, but they do occur.
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- Nitroglycerin Extended-Release Capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
From the official label · 2026-05-18 · DailyMed
How it works
From this product’s own US prescribing label.
The principal pharmacological action of nitroglycerin is relaxation of vascular smooth muscle and consequent dilation of peripheral arteries and veins, especially the latter.
Dilatation of the veins promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure and pulmonary capillary wedge pressure (preload).
The dinitrates are further metabolized to (non-vasoactive) mononitrates and, ultimately, to glycerol and carbon dioxide.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-05-18
Do not take it if
- Allergic reactions to organic nitrates are extremely rare, but they do occur.
- Nitroglycerin is contraindicated in patients who are allergic to it.
- Do not use nitroglycerin extended-release capsules in patients who are taking phosphodiesterase inhibitors (such as sildenafil, tadalafil, or vardenafil) for erectile dysfunction or pulmonary arterial hypertension.Concomitant use can cause severe drops in blood pressure.
- Do not use nitroglycerin extended-release capsules in patients who are taking soluble guanylate cyclase stimulators (such as riociguat).
- Concomitant use can cause hypotension.
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- As noted above (CLINICAL PHARMACOLOGY) , careful studies with other formulations of nitroglycerin have shown that maintenance of continuous 24-hour plasma levels of nitroglycerin result in tolerance (i.e. loss of clinical response).
- Every dosing regimen for Nitroglycerin Extended-Release Capsules should provide a daily nitrate-free interval
- avoid the development of this tolerance.
- The minimum necessary length of such an interval has not been defined, but studies with other nitroglycerin formulations have shown that 10-12 hours is sufficient.
- Large controlled studies with other formulations of nitroglycerin show that no dosing regimen with Nitroglycerin Extended-Release should be expected to provide more than about 12 hours of continuous anti-anginal efficacy per day.
- The pharmacokinetics of Nitroglycerin Capsules and the clinical effects of multiple-dose regimens, have not been well studied.
- In clinical trials, the initial regimen of nitroglycerin has been 2.5 to 6.5 mg three to four times a day, with subsequent upward dose adjustment guided by symptoms and side effects.
- In one trial, 5 of the 18 subjects were titrated up to a dose of 26 mg four times a day.
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- Amplification of the vasodilatory effects of nitroglycerin by phosphodiesterase inhibitors can result in severe hypotension.
- The time course and dose dependence of this interaction have not been studied.
- Appropriate supportive care has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion.
- The benefits of oral nitroglycerin in patients with acute myocardial infarction or congestive heart failure have not been established.
- If one elects to use nitroglycerin in these conditions, careful clinical or hemodynamic monitoring must be used to
- avoid the hazards of hypotension and tachycardia.
- Because the effects at capsules are so difficult to terminate rapidly, that are not recommended in these settings.
- PRECAUTIONS:
- General:
- Severe hypotension, particularly with upright posture, may occur with even small doses of nitroglycerin.
- This drug should therefore be used with caution in patients who may be volume depleted or who, for whatever reason, are already hypotensive.
- Hypotension induced by nitroglycerin may be accompanied by paradoxical bradycardia and increased angina pectoris.
- Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.
- As tolerance in other forms of nitroglycerin develops, the effect of sublingual nitroglycerin on exercise tolerance, although still observable, is somewhat blunted.
- In industrial workers who have had long-term exposure to unknown (presumably high) doses of organic nitrates, tolerance clearly occurs.
- Chest pain, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitrates from these workers, demonstrating the existence of true physical dependence.
- Some clinical trials in angina patients have provided nitroglycerin for about 12 continuous hours of every 24-hour day.
- During the nitrate-free intervals in some of these trials, anginal attacks have been more easily provoked than before treatment, and patients have demonstrated hemodynamic rebound and decreased exercise tolerance.
- The importance of these observations to the routine, clinical use at oral nitroglycerin is not known.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- Category C: Animal reproduction studies have not been conducted with nitroglycerin.
- It is also not known whether nitroglycerin can cause fetal harm when administered to a pregnant woman or whether it can affect reproductive capacity.
- Nitroglycerin should be given to a pregnant women only if clearly needed.
- It is not known whether nitroglycerin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nitroglycerin is administered to a nursing woman.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Other medicines
- The vasodilating effects of nitroglycerin may be additive with those of other vasodilators.
- Alcohol, in particular, has been found to exhibit additive effects of this variety.
- Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination.
- Dose adjustments of either class of agents may be necessary.
Quoted from the official label, section “Drug Interactions”.
If you take too much
In an emergency, call your local emergency number or a poison control centre.
- Hemodynamic Effects:
- The ill effects of nitroglycerin overdose are generally the results of nitroglycerin's capacity to induce vasodilation, venous pooling, reduced cardiac output, and hypotension.
- These hemodynamic changes may have protean manifestations, including increased intracranial pressure, with any or all of persistent throbbing headache, confusion, and moderate fever; vertigo; palpitations; visual disturbances; nausea and vomiting (possibly with colic and even bloody diarrhea); syncope (especially in the upright posture; air hunger and dyspnea, later followed by reduced ventilatory effort; diaphoresis, with the skin either flushed or cold and clammy; heart block and bradycardia; paralysis; coma; seizures; and death.
- Laboratory determinations of serum levels of nitroglycerin and its metabolites are not widely available, and such determinations have, in any event, no established role in the management of nitroglycerin overdose.
- No data are available to suggest physiological maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of nitroglycerin and its active metabolites.
- Similarly, it is not known which -if any- of these substances can usefully be removed from the body by hemodialysis.
- No specific antagonist to the vasodilator effects of nitroglycerin is known, and no intervention has been the subject of controlled study as a therapy of nitroglycerin overdose.
- Because the hypotension associated with nitroglycerin overdose is the result of venodilation and arterial hypovolemia, prudent therapy in this situation should be directed toward increase in central fluid volume.
- Passive elevation of the patient's legs may be sufficient, but intravenous infusion of normal saline or similar fluid may also be necessary.
- The use of epinephrine or other arterial vasoconstrictors in this setting is likely to do more harm than good.
- In patients with renal disease or congestive heart failure, therapy resulting in central volume expansion is not without hazard.
- Treatment of nitroglycerin overdose in these patients may be subtle and difficult, and Invasive monitoring may be required.
- Methemoglobinemia:
- Nitrate ions liberated during metabolism of nitroglycerin can oxidize hemoglobin into methemoglobin.
- Even in patients totally without cytochrome b5 reductase activity, however, and even assuming that the nitrate moieties of nitroglycerin are quantitatively applied to oxidation of hemoglobin, about 1mg/kg of nitroglycerin should be required before any of these patients manifests clinically significant (≥10%) methemoglobinemia.
- In patients with normal reductase function, significant production of methemoglobin should require even larger doses of nitroglycerin.
- In one study in which 36 patients received 2-4 weeks of continuous nitroglycerin therapy at 3.1 to 4.4 mg/hr, the average methemoglobin level measured 0.2%; this was comparable to that observed in parallel patients who received placebo.
- Not withstanding these observations, there are case reports of significant methemoglobinemia in association with moderate overdoses of organic nitrates.
- None of the affected patients had been thought to be unusually susceptible.
- Methemoglobin levels are available from most clinical laboratories.
- The diagnosis should be suspected in patients who exhibit signs of impaired oxygen delivery despite adequate cardiac output and adequate arterial pO2.
- Classically, methemoglobinemic blood is described as chocolate brown, without color change on exposure to air.
- When methemoglobinemia is diagnosed, the treatment of choice is methylene blue, 1 to 2 mg/kg intravenously.
Quoted from the official label, section “Overdosage”.
Use in children
Safety and effectiveness in children have not been established.
Quoted from the official label, section “Pediatric Use”.
Use in older people
- Geriatic Use:
- Clinical studies of Nitroglycerin Extended-Release Capsules did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
- Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
- In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Quoted from the official label, section “Geriatric Use”.
Side effects
- Adverse reactions to nitroglycerin are generally dose-related, and almost all of these reactions are the result of nitroglycerin's activity as a vasodilator.
- Headache, which may be severe, is the most commonly reported side effect.
- Headache may be recurrent with each daily dose, especially at higher doses.
- Transient episodes of lightheadedness, occasionally related to blood pressure changes, may also occur.
- Hypotension occurs infrequently, but in some patients may be severe enough to warrant discontinuation of therapy.
- Syncope, crescendo angina, and rebound hypertension have been reported but are uncommon.
- Allergic reactions to nitroglycerin are also uncommon, and the great majority of those reported have been cases of contact dermatitis or fixed drug eruptions in patients receiving nitroglycerin in ointments or patches.
- There have been a few reports of genuine anaphylactoid reactions, and these reactions can probably occur in patients receiving nitroglycerin by any route.
- Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal seeming patients; for further discussion of its diagnosis and treatment see OVERDOSAGE.
- Data are not available to allow estimation of the frequency of adverse reactions during treatment with Nitroglycerin Extended-Release Capsules.
Quoted from the official label, section “Adverse Reactions”.
What to discuss with your doctor
- Daily headaches sometimes accompany treatment with nitroglycerin.
- In patients who get these headaches, the headaches are a marker of the activity of the drug.
- Patients should resist the temptation to
- avoid headaches by altering the schedule of their treatment with nitroglycerin, since loss of headache is likely to be associated with simultaneous loss of anti-anginal efficacy.
- Treatment with nitroglycerin may be associated with lightheadedness on standing, especially just after rising from a recumbent or seated position.
- This effect may be more frequent in patients who have also consumed alcohol.
Quoted from the official label, section “Patient Counseling Information”.
What it looks like and how it is packed
- Nitroglycerin Extended-Release Capsules, 2.5 mg (Pink and Clear, imprinted TCL 1221) in 60 and 100 count bottles.
- Nitroglycerin Extended- Release Capsules, 6.5 mg (Blue and Yellow, imprinted TCL 1222) in 60 and 100 count bottles.
- Nitroglycerin Extended-Release Capsules, 9 mg (Green and Yellow, imprinted TCL 1223) in 60 and 100 count bottles. Rx only
Quoted from the official label, section “How Supplied”.
How to store it
- Store at controlled room temperature 25 °C (77 °F), excursions permitted between 15°-30 °C (59°-86 °F). Protect from moisture. Dispense in a tight container, as defined in the USP. Manufactured by:
- Time-Cap Labs, Inc. Farmingdale, NY 11735 Revised May 2026
Quoted from the official label, section “Storage and Handling”.
What is in it
- Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is:
- Molecular Formula:
- C3H5N3O9 Molecular Weight:
- 227.09 The organic nitrates are vasodilators, active on both arteries and veins.
- Each Extended-Release Capsule, for oral administration contains 2.5 mg, 6.5 mg or 9 mg of Nitroglycerin.
- The inactive ingredients in each capsule are corn starch, ethylcellulose, gelatin, lactose monohydrate, propylene glycol, shellac, sugar, talc, and wax.
- Additionally, the 2.5 mg capsule contains D&C Red #28, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40, FD&C Red #40 Aluminum Lake, Iron Oxide Black; the 6.5 mg capsule contains D&C Red #33, D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6, Simethicone, Titanium Dioxide; the 9 mg capsule contains D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Green #3, FD&C Red #40 Aluminum Lake, FD&C Yellow #6, Iron Oxide Black, Titanium Dioxide. nitroglycerin-description
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
- Lactose
lactose monohydrate
Milk sugar: matters with lactose intolerance or a milk allergy. - Colour dyes
the 2.5 mg capsule contains D&C Red #28; D&C Yellow #10; D&C Yellow #10 Aluminum Lake; FD&C Blue #1; FD&C Blue #1 Aluminum Lake; FD&C Blue #2 Aluminum Lake; FD&C Red #40; FD&C Red #40 Aluminum Lake; the 6.5 mg capsule contains D&C Red #33; FD&C Yellow #6; the 9 mg capsule contains D&C Yellow #10; FD&C Green #3
Some people react to dyes such as tartrazine (Yellow 5) or carmine. - Sugars
sugar
Relevant to diabetes and dental health. - Gelatin
gelatin
Animal-derived: matters for vegetarian, vegan, halal and kosher diets. - Titanium dioxide
Titanium Dioxide
A whitening agent no longer allowed in food in the EU (E171).
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
CanadaNo exact match for this strength and form
Details
| Made by | TIME CAP LABORATORIES, INC |
|---|---|
| Active substance | Nitroglycerin |
| Used in | Heart, blood pressure and circulation |
| Strength | 2.5 mg |
| Form | Capsule |
| Route | Oral |
| Packs | 60 CAPSULE in 1 BOTTLE, PLASTIC · 100 CAPSULE in 1 BOTTLE, PLASTIC |
| NDC | 49483-221 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
3 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.