Medicine guide

Thiamine

100 mg/mL · Injection, Solution

Prescription only

Active substance: Thiamine Hydrochloride
Made by: Fresenius Kabi USA, LLC
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 · 2026-01-14

Used for

Thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the…

The label’s usual adult dose

In the treatment of beriberi, 10 to 20 mg of thiamine hydrochloride are given IM three times daily for as long as two weeks.

Full directions ↓

Do not take it if

A history of sensitivity to thiamine or to any of the ingredients in this drug is a contraindication. (See WARNINGS for further information.)

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

15other products contain Thiamine Hydrochloride — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety.
Thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in Wernicke’s encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe.
It is also indicated when giving IV dextrose to individuals with marginal thiamine status to
avoid precipitation of heart failure.
Thiamine hydrochloride injection is also indicated in patients with established thiamine deficiency who cannot take thiamine orally due to coexisting severe anorexia, nausea, vomiting, or malabsorption.
Thiamine hydrochloride injection is not usually indicated for conditions of decreased oral intake or decreased gastrointestinal absorption, because multiple vitamins should usually be given.

From the official label · 2026-01-14 · DailyMed

How it works

From this product’s own US prescribing label.

The water soluble vitamins are widely distributed in both plants and animals.
They are absorbed in man by both diffusion and active transport mechanisms.

How it leaves the body

Metabolism is rapid, and the excess is excreted in the urine.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-01-14

Do not take it if

A history of sensitivity to thiamine or to any of the ingredients in this drug is a contraindication. (See WARNINGS for further information.)

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

“Wet” beriberi with myocardial failure must be treated as an emergency cardiac condition, and thiamine must be administered slowly by the IV route in this situation (see WARNINGS ).
In the treatment of beriberi, 10 to 20 mg of thiamine hydrochloride are given IM three times daily for as long as two weeks.
(See WARNINGS regarding repeated injections of thiamine.) An oral therapeutic multivitamin preparation containing 5 to 10 mg thiamine, administered daily for one month, is recommended to achieve body tissue saturation.
Infantile beriberi that is mild may respond to oral therapy, but if collapse occurs, doses of 25 mg may cautiously be given IV.
Poor dietary habits should be corrected and an abundant and well-balanced dietary intake should be prescribed.
Patients with neuritis of pregnancy in whom vomiting is severe enough to preclude adequate oral therapy should receive 5 to 10 mg of thiamine hydrochloride IM daily.
In the treatment of Wernicke-Korsakoff syndrome, thiamine hydrochloride has been administered IV in an initial dose of 100 mg, followed by IM doses of 50 to 100 mg daily until the patient is consuming a regular, balanced diet.
(See WARNINGS regarding repeated injections of thiamine.) Patients with marginal thiamine status to whom dextrose is being administered should receive 100 mg thiamine hydrochloride in each of the first few liters of IV fluid to
avoid precipitating heart failure.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

WARNING: This product contains aluminum that may be toxic.
Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired.
Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity.
Tissue loading may occur at even lower rates of administration.
Serious hypersensitivity/anaphylactic reactions can occur, especially after repeated administration.
Deaths have resulted from IV or IM administration of thiamine (see ADVERSE REACTIONS ).
Routine testing for hypersensitivity, in many cases, may not detect hypersensitivity.
Nevertheless, a skin test should be performed on patients who are suspected of drug allergies or previous reactions to thiamine, and any positive responders should not receive thiamine by injection.
If hypersensitivity to thiamine is suspected (based on history of drug allergy or occurrence of adverse reactions after thiamine administration), administer one-hundredth of the dose intradermally and observe for 30 minutes.
If no reaction occurs, full dose can be given; the patient should be observed for at least 30 minutes after injection.
Be prepared to treat anaphylactic reactions regardless of the precautions taken.
Treatment of anaphylactic reactions includes maintaining a patent airway and the use of epinephrine, oxygen, vasopressors, steroids and antihistamines.
General Simple vitamin B 1 deficiency is rare.
Multiple vitamin deficiencies should be suspected in any case of dietary inadequacy.
Information for Patients The patient should be advised as to proper dietary habits during treatment so that relapses will be less likely to occur with reduction in dosage or cessation of injection therapy.
Usage in Pregnancy Pregnancy Category A –Studies in pregnant women have not shown that thiamine hydrochloride increases the risk of fetal abnormalities if administered during pregnancy.
If the drug is used during pregnancy, the possibility of fetal harm appears remote.
Because studies cannot rule out the possibility of harm however, thiamine hydrochloride should be used during pregnancy only if clearly needed.
Nursing Mothers It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised when thiamine hydrochloride is administered to a nursing mother.
General Simple vitamin B 1 deficiency is rare. Multiple vitamin deficiencies should be suspected in any case of dietary inadequacy.
The patient should be advised as to proper dietary habits during treatment so that relapses will be less likely to occur with reduction in dosage or cessation of injection therapy.
Usage in Pregnancy Pregnancy Category A –Studies in pregnant women have not shown that thiamine hydrochloride increases the risk of fetal abnormalities if administered during pregnancy.
If the drug is used during pregnancy, the possibility of fetal harm appears remote.
Because studies cannot rule out the possibility of harm however, thiamine hydrochloride should be used during pregnancy only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when thiamine hydrochloride is administered to a nursing mother.

Quoted from the official label, section “Warnings”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Parenteral doses of 100 to 500 mg singly have been administered without toxic effects.
However, dosages exceeding 30 mg three times a day are not utilized effectively.
When the body tissues are saturated with thiamine, it is excreted in the urine as pyrimidine.
As the intake of thiamine is further increased, it appears unchanged in the urine.

Quoted from the official label, section “Overdosage”.

Side effects

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
An occasional individual may develop a hypersensitivity or life-threatening anaphylactic reaction to thiamine, especially after repeated injections.
Collapse and death have been reported.
A feeling of warmth, pruritus, urticaria, weakness, sweating, nausea, restlessness, tightness of the throat, angioneurotic edema, cyanosis, pulmonary edema, and hemorrhage into the gastrointestinal tract have also been reported.
Some tenderness and induration may follow IM use (see WARNINGS ).

Quoted from the official label, section “Adverse Reactions”.

What it looks like and how it is packed

Thiamine Hydrochloride Injection, USP is supplied as follows:
Product Code Unit of Sale Strength Each NP1302 NDC 63323-013-09 Unit of 25 200 mg per 2 mL (100 mg per mL) NDC 63323-013-21 2 mL Multiple Dose Vial
Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].
PROTECT FROM LIGHT.
Use only if solution is clear and seal intact.
Novaplus is a registered trademark of Vizient, Inc.

Quoted from the official label, section “How Supplied”.

What is in it

Rx only
Thiamine Hydrochloride Injection, USP is a sterile solution of thiamine hydrochloride in Water for Injection for intramuscular (IM) or slow intravenous (IV) administration.
Each mL contains:
Thiamine hydrochloride 100 mg; chlorobutanol anhydrous (chloral derivative) 0.5%; monothioglycerol 0.5%; water for injection, q.s.
Sodium hydroxide may have been added for pH adjustment (2.5 to 4.5).
Thiamine hydrochloride, or vitamin B 1 , occurs as white crystals or crystalline powder that usually has a slight characteristic odor.
Freely soluble in water; soluble in glycerin; slightly soluble in alcohol; insoluble in ether and benzene.
Thiamine is rapidly destroyed in neutral or alkaline solutions but is stable in the dry state.
It is reasonably stable to heat in acid solution.
The chemical name of thiamine hydrochloride is thiazolium,3-[(4-amino-2-methyl-5-pyrimidinyl)methyl]-5-(2-hydroxyethyl)-4-methylchloride, monohydrochloride and it has the following structural formula:
Thiamine Structure

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.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

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.

Every version of this medicine (15)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 15 of 15

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.

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CanadaNo exact match for this strength and form

Every strength and form (4)

Details

Made by	Fresenius Kabi USA, LLC
Active substance	Thiamine Hydrochloride
Strength	100 mg/mL
Form	Injection, Solution
Route	Intramuscular; Intravenous
Packs	25 VIAL, MULTI-DOSE in 1 TRAY / 2 mL in 1 VIAL, MULTI-DOSE
NDC	63323-013

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).

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Other strengths and forms

4 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Injection, Solution4 products
- 100 mg/mL4
  100 mg/mL · 4 companies
  - Armas Pharmaceuticals Inc.
  - Caplin Steriles Limited
  - Fresenius Kabi USA, LLC · this page
  - NorthStar Rx LLC

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Thiamine Hydrochloride