Select-ob Plus Dha Prenatal Supplement Plus Dha
.beta.-carotene, Vitamin A Acetate, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Levomefolate Calcium, Cobalamin, Iron, Magnesium Oxide, Zinc Oxide, And Doconexant
Exeltis Usa, Inc.
Human Prescription Drug
NDC 0642-0075Select-ob Plus Dha Prenatal Supplement Plus Dha also known as .beta.-carotene, Vitamin A Acetate, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Levomefolate Calcium, Cobalamin, Iron, Magnesium Oxide, Zinc Oxide, And Doconexant is a human prescription drug labeled by 'Exeltis Usa, Inc.'. National Drug Code (NDC) number for Select-ob Plus Dha Prenatal Supplement Plus Dha is 0642-0075. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Select-ob Plus Dha Prenatal Supplement Plus Dha drug includes . The currest status of Select-ob Plus Dha Prenatal Supplement Plus Dha drug is Active.
Drug Information:
| Drug NDC: | 0642-0075 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Select-ob Plus Dha Prenatal Supplement Plus Dha |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Select-ob Plus Dha |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Prenatal Supplement Plus DHA |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | .beta.-carotene, Vitamin A Acetate, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Levomefolate Calcium, Cobalamin, Iron, Magnesium Oxide, Zinc Oxide, And Doconexant |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Exeltis Usa, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 08 Apr, 2009 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Exeltis USA, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1100198
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0642-0075-30 | 1 KIT in 1 CARTON (0642-0075-30) * 30 TABLET, COATED in 1 BOX * 30 CAPSULE in 1 BOX | 08 Apr, 2009 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Select-ob plus dha prenatal supplement plus dha .beta.-carotene, vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, levomefolate calcium, cobalamin, iron, magnesium oxide, zinc oxide, and doconexant select-ob .beta.-carotene, vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, levomefolate calcium, cobalamin, iron, magnesium oxide, and zinc oxide fructose stearic acid croscarmellose sodium diacetyltartaric and fatty acid esters of glycerol silicon dioxide citric acid monohydrate titanium dioxide gelatin, unspecified magnesium stearate malic acid hydroxypropyl cellulose (1600000 wamw) triacetin starch, corn sucrose modified corn starch (1-octenyl succinic anhydride) hypromellose, unspecified anhydrous dibasic calcium phosphate fd&c blue no. 1 fd&c blue no. 2 sodium ascorbate medium-chain triglycerides sorbic acid tocopherol sodium benzoate .alpha.-tocopherol, dl- butylated hydroxytoluene tricalcium phosphate polydextrose polyethylene glycol, unspecified beta carotene beta carotene vitamin a acetate vitamin a ascorbic acid ascorbic acid cholecalciferol cholecalciferol .alpha.-tocopherol acetate, dl- .alpha.-tocopherol, dl- thiamine mononitrate thiamine ion thiamine riboflavin riboflavin niacinamide niacinamide pyridoxine hydrochloride pyridoxine folic acid folic acid levomefolate calcium levomefolic acid cobalamin cobalamin iron iron magnesium oxide magnesium cation zinc oxide zinc oxide ev0077 mixed berry dha doconexant glycerin gelatin, unspecified water doconexent doconexent amber
Drug Interactions:
Drug interactions high doses of folic acid may result in decreased serum levels of the anticonvulsant drugs. vitamin d supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. zinc can inhibit the absorption of certain antibiotics; take at least 2 hours apart to minimize interactions. consult appropriate references for additional specific vitamin-drug interactions.
Boxed Warning:
Warning accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. keep this product out of reach of children. in case of accidental overdose, call a doctor or a poison control center immediately.
Indications and Usage:
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.* select-ob+dha ® does not contain fish, fish oils, fish proteins or fish byproducts.
Warnings:
Warnings/precautions select-ob+dha ® should be used with caution in patients with known sensitivity or allergy to soy. vitamin d supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. high doses of vitamin d can lead to elevated levels of calcium that reside in the blood and soft tissues. bone pain, high blood pressure, formation of kidney stones, renal failure, and increased rick of heart disease can occur. prolonged use of iron slats may produce iron storage disease. folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive. the use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin b12 deficiency. consumption of more than 3 grams of omega-3 fatty acids per day from all sour
Read more...ces may lead to excessive bleeding. supplemental intake of omega-3 fatty acids such as dha exceeding 2 grams per day is not recommended. avoid overdosage. keep out of the reach of children. drug interactions high doses of folic acid may result in decreased serum levels of the anticonvulsant drugs. vitamin d supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. zinc can inhibit the absorption of certain antibiotics; take at least 2 hours apart to minimize interactions. consult appropriate references for additional specific vitamin-drug interactions. information for patients patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding. pediatric use not for pediatric use.
Dosage and Administration:
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.
Contraindications:
Contraindications select-ob+dha ® is contraindicated in patients with hypersensitivity to any of its components or color additives. folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver. cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitaminb12).
Adverse Reactions:
Adverse reactions adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in select-ob+dha ® .
Drug Interactions:
Drug interactions high doses of folic acid may result in decreased serum levels of the anticonvulsant drugs. vitamin d supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. zinc can inhibit the absorption of certain antibiotics; take at least 2 hours apart to minimize interactions. consult appropriate references for additional specific vitamin-drug interactions.
Pediatric Use:
Pediatric use not for pediatric use.
Description:
Composition each select-ob ® caplet contains: vitamin a (as retinyl acetate & beta carotene) 510 mcg rae (1700 iu) vitamin c (as ascorbic acid) 60 mg vitamin d (as cholecalciferol) 10 mcg (400 iu) vitamin e (as dl-alpha tocopheryl acetate) 13.5 mg (30 iu) thiamin (vitamin b1 as thiamine mononitrate) 1.6 mg riboflavin (vitamin b2) 1.8 mg niacin (as niacinamide) 15 mg ne vitamin b6 (as pyridoxine hydrochloride) 2.5 mg folate (as folic acid) 1700 mcg dfe vitamin b12 (as cyanocobalamin) 5 mcg iron (as polysaccharide iron complex) 29 mg magnesium (as magnesium oxide) 25 mg zinc (as zinc oxide) 15 mg each softgel capsule contains: docosahexaenoic acid (dha) (from natural algal oil) 250 mg 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.
How Supplied:
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 (5 child resistant blister cards of 6 select-ob ® caplets and 6 dha softgel capsules each) (0642-0075-30) and as professional samples (0642-0075-03). store at room temperature, approximately 15°-30°c (59°-86°f), avoid excessive heat and moisture.
Information for Patients:
Information for patients patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.
Package Label Principal Display Panel:
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 natural source dha smaller dha softgel does not contain fish oil r x unit dose pack 30 caplets and 30 softgel capsules u.s. patented principal display panel - kit carton