Select-OB +DHA

Original facts and normalized results

Label statements

These are explicitly classified as label claims. They are not converted into platform-endorsed scientific conclusions.

• label_claim Brand IP Statement(s) re: (c), (TM), (SM): U.S. Patent No. 7,560,123; 5,407,957; 5,492,938; 7,163,811 and other patents pending Select-OB(R) is a trademark of Everett Laboratories, Inc.
• label_claim Storage: Store at room temperature, approximately 15(0)-30(0)C (59(0)-86(0)F), avoid excessive heat.
• label_claim General Statements: All Other Content: Prenatal Supplement with DHA
• label_claim Precautions re: All Other: ADVERSE RECTIONS: Advers reactions have been reported with specinc vitamins and minerals, but generally at doses substantially higher than those in SELECT-OB(R)+DHA. However, allergic and idiosyncratic reactions are possible at any dose. Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.
• label_claim Suggested/Recommended/Usage/Directions: DOSAGE AND ADMINISTRATION: Before, during and after pregnancy, chew or swallow one blue SELECT-OB(R) caplet and swallow one DHA gel capsule daily, or as directed by a physician.
• label_claim Precautions re: All Other: CONTRAINDICATIONS: SELECT-OB(R)+DHA is contraindicated in patients with hypersensitivity to any of its components. Folic acid (pteroylglutamic acid) is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. lron 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, (vitamin B12).
• label_claim Precautions re: All Other: Drug Interactions: High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbitol, valproic acld. Vitamin D supplementation should not be given with large amounts of calcium in those with hypercaloemia 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; taken at least 2 hours apart to minimize interactions.Consult appropriate references for additional specific vitamin-drug interactions.
• label_claim Precautions re: Children: 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.
• label_claim Precautions re: Children: Pediatric Use: Not for pediatric use.
• label_claim Suggested/Recommended/Usage/Directions: INDICATIONS AND USAGE: SELECT-OB(R)+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(R)+DHA does not contain fish, fish oils, fish proteins or fish byproducts.
• label_claim General Statements: All Other Content: DESCRIPTIDN: 30 SELECT-OB(R) caplets and 30 DHA capsules are co-packaged in child-resistant blister cards for prescription use. SELECT-OB(R) is a light blue caplet, imprint "EV0O77". DHA is contained in an amber-colored gelatin capsule. HOW SUPPLIED: Box of Unit-Dose pack of 30 (6 child resistant blister cards of 5 Select-OB(R) caplets and 5 DHA gel capsules each), (NDC 0642- 0075-30).
• label_claim Precautions re: All Other: 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 risk of heart disease can occur. Prolonged use of iron salts may produce iron storage disease. Folic acid, especially in doses above 0.1 mg daily, may obscure pemicious 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 B-12 deficiency. Consumption of more than 3 grams of omega~3 fatty acids per day from all sources may lead to exoessive bleeding. Supplemental intake of omega—3 fatty acids such as DHA exceeding 2 grams per day is not recommended. Avoid Overdosage.
• label_claim Precautions re: All Other: Rx only
• label_claim Precautions re: Children: Keep out of reach of children.
• label_claim Precautions re: Pregnant or Nursing or Prescription Medications: Information for Patients: Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breast-feeding.
• label_claim General: Product/Version Code: (Rev. 09/11)
• label_claim Precautions re: Allergies: WARNINGS/PRECAUTIONS: SELECT-OB(R)+DHA should be used with caution in patients with known sensitivity or allergy to soy.

Ingredient references

Reference pages provide verified source mappings. Unless a real review record exists, they remain reference-only with no medical summary or evidence grade.

• Vitamin A reference index
• Vitamin C reference index
• Vitamin D reference index
• Vitamin E reference index
• Thiamin reference index
• Riboflavin reference index
• Niacin reference index
• Vitamin B6 reference index
• Folate reference index
• Vitamin B12 reference index
• Iron reference index
• Magnesium reference index

Source and version

Original record

NIH ODS DSLD label 13114

Local snapshot

snap_dsld_13114_a8f6a208ae14dcdaf768950f

Content hash

a8f6a208ae14dcdaf768950ff137ffe137fe12ae08937d41c9887a43cfb0df8f

Source version

(Rev. 09/11)

Limitations

• This record reports label facts from a US-market source snapshot, not current inventory or product safety.
• Label quantity comparisons do not establish absorption, efficacy, safety, or clinical equivalence.

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