MASOOD BIOGEN 21 ORACURE- calcarea phosphoricum tablet

Masood Biogen 21 Oracure by

Drug Labeling and Warnings

Masood Biogen 21 Oracure by is a Homeopathic medication manufactured, distributed, or labeled by Dr. Masood Homeopathic Pharmaceuticals Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Directions:

As directed by a Licensed Homoeopathic Practitioner.

• Infants up to 5 to 6 months: 1 Tablet after every 4 hours.
• Infants above 6 months: 2 Tablets after every 4 hours.

INDICATIONS & USAGE

Uses:

Temporarily relieves running colic due to delayed teething. *

*The uses for this product is based on traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

ACTIVE INGREDIENT

Active Ingredients

• Calcarea Phosphoricum
• Ferrum Phosphoricum

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

PURPOSE

Purpose

• Temporary Relief - Running Colic Due to Delayed teething*
• To be used for acute self-limiting conditions according to standard homeopathic indications

INACTIVE INGREDIENT

Inactive ingredients

Sodium Starch Glycolate, Starch, Gelatin, Magnesium Stearate

WARNINGS

Warnings:

Do not:

• use if you have an allergy or hypersensitivity to components of the formula
• If pregnant or breast feeding, ask a licensed homeopathic practitioner before use

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MASOOD BIOGEN 21 ORACURE 
calcarea phosphoricum tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82797-321
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	48 mg
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	48 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)	1.2 mg
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)	0.76 mg
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) (UNII: 9M44R3409A)	2.6 mg
GELATIN (UNII: 2G86QN327L)	0.2 mg

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	3mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82797-321-21	1 in 1 BOX	12/01/2022
1	NDC: 82797-321-20	190 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/01/2022

Labeler - Dr. Masood Homeopathic Pharmaceuticals Private Limited (645453119)

Registrant - Dr. Masood Homeopathic Pharmaceuticals Private Limited (645453119)

Establishment
Name	Address	ID/FEI	Business Operations
Dr. Masood Homeopathic Pharmaceuticals Private Limited		645453119	manufacture(82797-321) , pack(82797-321) , label(82797-321)