BILBERRY: 11 Adverse Event Reports & Safety Profile
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Route: ORAL · Manufacturer: Professional Complementary Health Formulas · HUMAN OTC DRUG · FDA Label: Available
First Report: 20180305 · Latest Report: 20180305
What Are the Most Common BILBERRY Side Effects?
All BILBERRY Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Anaemia | 7 | 63.6% | 4 | 7 |
| Drug intolerance | 5 | 45.5% | 4 | 4 |
| Off label use | 5 | 45.5% | 4 | 4 |
Who Reports BILBERRY Side Effects? Age & Gender Data
Gender: 36.4% female, 63.6% male. Average age: 74.6 years. Most reports from: CA. View detailed demographics →
Is BILBERRY Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2018 | 1 | 0 | 0 |
Official FDA Label for BILBERRY
Official prescribing information from the FDA-approved drug label.
Drug Description
DESCRIPTION: PRENATE CHEWABLE ® is a prescription prenatal/postnatal multivitamin/mineral chocolate chewable tablet. Each tablet is brown and imprinted with "Prenate Chew" on one side and blank on the other. supplement
FDA Approved Uses (Indications)
INDICATIONS: PRENATE CHEWABLE ® is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. PRENATE CHEWABLE ™ can also be beneficial in improving the nutritional status of women prior to conception.
Dosage & Administration
DIRECTIONS Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.
Contraindications
CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Known Adverse Reactions
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Warnings
WARNINGS Consult a doctor if condition worsens or if symptoms persist. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use. Keep out of the reach of children. If pregnant or breastfeeding, ask a healthcare professional before use.
Precautions
PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
Active Ingredient
Active Ingredients Rubus Fruticosus 2xHPUS Iris Germanica 4xHPUS Vaccinium Myrtillus 3xHPUS Syzygium Jambolanum 3xHPUS Okoubaka Aubrevillei 6xHPUS The letters HPUS indicates that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of United Sates.
Purpose
For temporary relief of pancreatic discomforts. Keep out of reach of children. Suggested use Dosage: For acute conditions take 25 drops in water 3-4 times daily. For long-term usage, take 20 drops in water morning and evening. Dosage: For acute conditions take 25 drops in water 3-4 times daily. For long-term usage, take 20 drops in water morning and evening. Warnings If pregnant or breast-feeding, consult a health professional before use. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. (Read Suggested Use Section)
Inactive Ingredients
Ethyl alcohol (52% by vol.) and Water
Inactive Ingredients
OTHER INGREDIENTS: Chocolate Flavor, Gum Acacia, Fructose, Magnesium Stearate, Natural Dutch Chocolate, Silicone Dioxide and Silica (as Sipernat ® ), and Hydrogenated Vegetable Oil (as Sterotex ® ).