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  5. Label Information: Select-ob Plus Dha Prenatal Supplement Plus Dha

FDA Label for Select-ob Plus Dha Prenatal Supplement Plus Dha

View Indications, Usage & Precautions

Table of Contents

    1. DESCRIPTION
    2. INDICATIONS AND USAGE
    3. WARNING
    4. DOSAGE AND ADMINISTRATION
    5. HOW SUPPLIED
    6. STORAGE AND HANDLING
    7. OTHER
    8. PRINCIPAL DISPLAY PANEL - KIT CARTON

Select-ob Plus Dha Prenatal Supplement Plus Dha Product Label

The following document was submitted to the FDA by the labeler of this product Exeltis Usa, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Description



Prenatal Supplement with DHA

Supplement Facts
Serving Size 1 Caplet and 1 Softgel Capsule
Each Caplet contains% Daily Value in Pregnancy
Vitamin A (as acetate and beta carotene)1700 IU 21%
Vitamin C (as ascorbic acid)60 mg100%
Vitamin D3 (as cholecalciferol) 400 IU 100%
Vitamin E (as dl-alpha tocopheryl acetate) 30 IU 100%
Thiamine Mononitrate (Vitamin B1)1.6 mg94%
Riboflavin (Vitamin B2)1.8 mg90%
Niacin (as niacinamide)15 mg75%
Vitamin B6 (as pyridoxine hydrochloride)2.5 mg100%
Folic acid1 mg125%
Vitamin B12 (as cyanocobalamin) 5 mcg63%
Elemental Iron (as polysaccharide iron complex)29 mg161%
Magnesium (as magnesium oxide)25 mg6%
Zinc (as zinc oxide)15 mg100%
Each Softgel Capsule contains
Algal oil blend
  (derived from crypthecodinium cohnii)		486 mg

(providing 250mg DHA (docosahexaenoic acid))

Daily Value not established

Other Ingredients in Select-OB® Caplet: Fructose, Stearic Acid, Mono and Diglycerides, Croscarmellose Sodium, Mixed Berry Flavor WONF, Gelatin (Porcine), Silicon Dioxide, Citric Acid, Magnesium Stearate, Modified Food Starch, Hydroxypropylmethyl Cellulose, Malic Acid, Sucrose, Corn Starch, Dicalcium Phosphate, Sodium Ascorbate, Medium Chain Triglycerides, Sorbic Acid, Tocopherol Concentrate, Sodium Benzoate, dl-Alpha-Tocopherol, Butylated Hydroxytoluene (BHT), Tricalcium Phosphate. Coating: Hydroxypropylmethyl Cellulose, Titanium Dioxide, Polydextrose, Hydroxypropyl Cellulose, Triacetin, Polyethylene Glycol, FD&C Blue #1 / Aluminum Lake, FD&C Blue #2 / Aluminum Lake. Contains: Soy.

Other Ingredients in DHA Softgel Capsule: Gelatin, Glycerin USP, Water.


Indications And Usage



Select-OB®+DHA is indicated to provide vitamin, mineral, and omega-3 fatty acid supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother, including individuals with known allergies to fish. Select-OB®+DHA does not contain fish, fish oils, fish proteins or fish byproducts.


Warning



Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or a Poison Control Center immediately.


Dosage And Administration



Before, during and after pregnancy, chew or swallow one blue Select-OB® caplet and swallow one DHA softgel capsule daily, or as directed by a physician.


How Supplied



Select-OB®+DHA is available as a light blue caplet debossed EV0077 and one amber-colored DHA softgel capsule. Available in Box of Unit-Dose pack of 30 (6 child resistant blister cards of 5 Select-OB® caplets and 5 DHA softgel capsules each), (0642-0075-30) and as professional samples (0642-0075-03).


Storage And Handling



Store at room temperature, approximately 15°-30°C (59°-86°F), avoid excessive heat and moisture.


Other



Rx

See package insert for full prescribing information

Manufactured for
EVERETT LABORATORIES, INC. Chatham, NJ 07928
1-877-324-9349

U.S. Patent No. 7,560,123; 8,101,587; 8,197,855 and 8,609,629
Select-OB® is a trademark of Everett Laboratories, Inc.
life'sDHA is a trademark of DSM.
U.S. Patent No. 7,163,811and 7,824,892
(Rev. 03/14)

(Rev. 03/14)


Principal Display Panel - Kit Carton



0642-0075-30

Select-OB®+DHA

Prenatal Supplement with DHA

Berry flavored BLUE Select-OB® Caplet
can be chewed or swallowed

DHA Softgel Capsule
from plant source DHA

New
Smaller DHA Softgel

DOES NOT CONTAIN
FISH OIL

life's DHA
HEALTHY BRAIN, EYES, HEART

Unit Dose Pack
30 Caplets and 30 Softgel Capsules

Rx

U.S. PATENTED


* Please review the disclaimer below.