Select-ob Plus Dha Kit
FDA Label NDC 0642-0075

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Exeltis Usa, Inc. for the product Select-ob Plus Dha (NDC 0642-0075). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding description, indications and usage, warning, dosage and administration, how supplied, storage and handling, other, principal display panel - kit carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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