Package insert / product label
Dosage form: injection
Drug class: Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Aug 22, 2022.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

DESCRIPTION:

Vitamin B-Complex 100 Injection is a sterile solution for intramuscular or slow intravenous injection comprised of vitamins which may be categorized as belonging to the Vitamin B Complex group. Each mL contains: Thiamine Hydrochloride 100 mg, Riboflavin 5’ Phosphate Sodium 2 mg, Pyridoxine Hydrochloride 2 mg, Dexpanthenol 2 mg, Niacinamide 100 mg, with Benzyl Alcohol 2% as preservative, in Water for Injection. Sodium Hydroxide and/or Hydrochloric Acid may have been used to adjust pH.

INDICATIONS AND USAGE:

In disorders requiring parenteral administration of vitamins, i.e. pre- and post-operative treatment, when requirements are increased as in fever, severe burns, increased metabolism, pregnancy, gastrointestinal disorders interfering with intake or absorption of vitamins, prolonged or wasting diseases, alcoholism and where other deficiencies exist.

CONTRAINDICATIONS:

Sensitivity to the ingredients listed

WARNINGS:

Anaphylactogenesis may occur with parenteral thiamine. Use with caution. An intradermal test dose is recommended prior to administration in patients suspected of being sensitive to the drug.

PRECAUTIONS:

The usual precautions for parenteral administration should be observed. Do not inject if precipitation occurs. Inject slowly by the intravenous route. High concentrations should be diluted using Normal Saline Injection when given intravenously.

ADVERSE REACTIONS:

Mild transient diarrhea, polycythemia vera, peripheral vascular thrombosis, itching transitory exanthema, feeling of swelling of entire body, anaphylactic shock and death. Sensitivity to the ingredients listed may occur (see WARNINGS). Use should be discontinued upon observance of any untoward reaction. Pain upon intramuscular injection may be noted.

DOSAGE AND ADMINISTRATION:

Usually 0.25 to 2 mL by intramuscular or slow intravenous injection. High concentrations given intravenously may be diluted using parenteral infusion solutions. (See PRECAUTIONS.)

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit (see HOW SUPPLIED).

HOW SUPPLIED:

Vitamin B-Complex 100 Injection
NDC 71414-225-01
30 mL Multi-Dose Vial, individually boxed.

Rx Only.

Phase separation due to reduced solubility can occur under certain conditions of shipping or storage (e.g. accidental freezing), which may produce visible particles. Do not use product if these do not redissolve on warming to body temperature and shaking well. Refrigeration of the product may cause darkening of the solution due to the riboflavin content. The colour does not affect the safety or efficacy of the product.

PROTECT FROM LIGHT:
Store in carton until contents are used.
Store under refrigeration 2° to 8°C (36° to 46°F).
Do not permit to freeze.

Manufactured for:

FLON LABORATORIES LLC

Elkhorn, NE 68022 U.S.A
www.flonlabs.com

225PI

REV: 06/17

Package Labeling:

Frequently asked questions

• What is Foltanx prescribed for?

Medical Disclaimer

Generic name: thiamine (vitamin B1) [ THIGH-a-min ]
Drug class: Vitamins

Medically reviewed by Drugs.com on Nov 23, 2022. Written by Cerner Multum.

What is thiamine?

Vitamin B1 is also known as thiamine. Vitamin B1 is found in foods such as cereals, whole grains, meat, nuts, beans, and peas. Vitamin B1 is important in the breakdown of carbohydrates from foods into products needed by the body.

Thiamine is used to treat or prevent vitamin B1 deficiency. Thiamine injection is used to treat beriberi, a serious condition caused by prolonged lack of vitamin B1.

Thiamine taken by mouth (oral) is available without a prescription. Injectable thiamine must be given by a healthcare professional.

Thiamine may also be used for purposes not listed in this medication guide.

Warnings

You should not use thiamine if you have ever had an allergic reaction to it.

Ask a doctor or pharmacist before taking thiamine if you have any medical conditions, if you take other medications or herbal products, or if you are allergic to any drugs or foods.

Before you receive injectable thiamine, tell your doctor if you have kidney disease.

Thiamine is only part of a complete program of treatment that may also include a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you should eat or avoid to help control your condition.

Before taking this medicine

You should not use thiamine if you have ever had an allergic reaction to it.

Ask a doctor or pharmacist if it is safe for you to take Vitamin B1 if:

• you have any other medical conditions;

• you take other medications or herbal products; or

• you are allergic to any drugs or foods.

To make sure you can safely receive injectable thiamine, tell your doctor if you have kidney disease.

Thiamine is not expected to harm an unborn baby. Your thiamine dose needs may be different during pregnancy. Do not take thiamine without medical advice if you are pregnant or plan to become pregnant.

It is not known whether thiamine passes into breast milk. Your dose needs may be different while you are nursing. Do not take thiamine without medical advice if you are breast-feeding a baby.

How should I take thiamine?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Injectable thiamine is injected into a muscle. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Do not use the injectable medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

The recommended dietary allowance of thiamine increases with age. Follow your healthcare provider''s instructions. You may also consult the National Academy of Sciences "Dietary Reference Intake" or the U.S. Department of Agriculture''s "Dietary Reference Intake" (formerly "Recommended Daily Allowances" or RDA) listings for more information.

Thiamine is only part of a complete program of treatment that may also include a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you should eat or avoid to help control your condition.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking thiamine?

Follow your doctor''s instructions about any restrictions on food, beverages, or activity.

Thiamine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• blue colored lips;

• chest pain, feeling short of breath;

• black, bloody, or tarry stools; or

• coughing up blood or vomit that looks like coffee grounds.

Less serious side effects may include:

• nausea, tight feeling in your throat;

• sweating, feeling warm;

• mild rash or itching;

• feeling restless; or

• tenderness or a hard lump where a thiamine injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect thiamine?

There may be other drugs that can interact with thiamine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Copyright 1996-2023 Cerner Multum, Inc. Version: 3.02.