RESTORA RX (folic acid, lactobacillus casei- ke-99 capsule

RESTORA RX by

Drug Labeling and Warnings

RESTORA RX by is a Other medication manufactured, distributed, or labeled by U.S. Pharmaceutical Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

Supplements Facts

Serving Size: 1 Capsule            Servings Per Carton: 30

                                                                                           % Daily Value for

                                                                                                    Pregnant or

Amount Per Serving                                           %DV*         Lactating Women

Folic acid                                    1.25mg           313%                         156%

Lactobacillue casei (KE-99),          60 mg              †                                   †

200 Billion CFU/g ** 

 † Daily value not established;  *% Daily value based on 2000 calorie

intake for adults and children 12 years and older; ** Colony Forming

Units per gram (CFU/g) at time of manufacturing

Folic Acid: Folic acid is one of the important hematopoietic agents necessary for proper regeneration of the blood-forming elements and their function. Additionally, folic acid increases jejunal glycolytic enzymes and is involved in the desaturation and hydroxylation of long-chain fatty acids in the brain. A deficiency in folic acid results in megaloblastic anemia.

WARNINGS

WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

PRECAUTIONS

PRECAUTIONS: As with other nutritional supplements, consult a physician if you are taking medications, diabetic, are pregnant or nursing; keep out of the reach of the children and pets.

Folic acid in doses above 0.1 mg - 0.4 mg daily may obscure the signs and symptoms of pernicious anemia, in that hematological remission can occur while neurological manifestations remain progressive. The use of this product by immunocompromised patients or treatment of any disorder must be medically supervised by a physician.

CAUTION: Rx only.

SAFE HANDLING WARNING

Store at controlled room temperature 15° to 30°C (59° to 86°F). Keep in a cool, dry place.

DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION: Adults (persons over 12 years of age), one (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dosage. Do not administer to children under the age of 12. You should contact your healthcare provider for medical advice about adverse events. To report a serious adverse event, contact US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036.

HOW SUPPLIED: Restora RxTM are light blue opaque capsules printed with “US” logo and “R207” in white. Child resistant bottles of 30 capsules NDC# 52747-207-30. Dispense in a tight, light resistant container as defined in the USP/NF with a child resistant closure. Manufactured with Vcaps® Plus capsule shells.

Marketed by US Pharmaceutical Corporation.
Vcaps® and the Vcaps® Logo are trademarks used under license.

HEALTH CLAIM

Nutritional Supplement enhanced with Lactobacillus casei KE-99

Packaging

INGREDIENTS AND APPEARANCE

RESTORA RX 
folic acid, lactobacillus casei (ke-99) capsule

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:52747-207
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1.25 mg
LACTOBACILLUS CASEI (UNII: SA940P2U00) (LACTOBACILLUS CASEI - UNII:SA940P2U00)	LACTOBACILLUS CASEI	60 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LINSEED OIL (UNII: 84XB4DV00W)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:52747-207-30	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
dietary supplement		12/01/2014

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
shape
size (solid drugs)	22 mm
scoring	1
imprint

Labeler - US Pharmaceutical Corporation (048318224)

Establishment
Name	Address	ID/FEI	Business Operations
Altora Pharma Solutions		044404586	manufacture(52747-207)