Focalgin B

Name: Focalgin B

Focalgin B tablet
Focalgin B drug
Focalgin B side effects
Focalgin B effects of

Contraindications

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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NDC 58657-105-60
FOCALGIN-B
TABLETS
Rx ONLY
60 TABLETS

Focalgin B
pyridoxine hydrochloride, folic acid, calcium, and ginger tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG LABEL	Item Code (Source)	NDC:58657-105
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE)	PYRIDOXINE HYDROCHLORIDE	42 mg
FOLIC ACID (FOLIC ACID)	FOLIC ACID	1.22 mg
CALCIUM (CALCIUM)	CALCIUM	124.23 mg
GINGER (GINGER)	GINGER	100 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
STARCH, CORN
HYPROMELLOSES
TITANIUM DIOXIDE
POLYDEXTROSE
TALC
MALTODEXTRIN
MEDIUM-CHAIN TRIGLYCERIDES
FERRIC OXIDE RED

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL (caplet)	Size	16mm
Flavor		Imprint Code	M;105
Contains

Packaging
#	Item Code	Package Description
1	NDC:58657-105-60	60 TABLET, FILM COATED in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		11/01/2013

Labeler - Method Pharmaceuticals, LLC (060216698)

Revised: 10/2013 Method Pharmaceuticals, LLC

Uses of Focalgin-B

This vitamin is used to aid the diet needs before, during, and after pregnancy.

What are some things I need to know or do while I take Focalgin-B?

Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Focalgin-B.
If you have phenylketonuria (PKU), talk with your doctor. Some products have phenylalanine.
Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Black, tarry, or bloody stools.
Fever.
Very upset stomach or throwing up.
Very bad belly pain.
Throwing up blood or throw up that looks like coffee grounds.
Stomach cramps.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of Focalgin-B may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.