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Major Pharmaceuticals

Oyster Shell Calcium 500 mg + D

Serving
1 Tablet(s)
Form
tablet
UPC
309045460610
DSLD
201612
Formula hash
2986baf7a1e5
Catalog
19
products
With avoid flag
12
products
FDA recalls
0
history
CAERS
1
reports
Avoid-flaggedObjective label signals
Flagged excipients
4
1 avoid · 3 caution
FDA recalls
0
no recall history
CAERS reports
1
FDA consumer events
Certifications
0
none recorded
1 avoid-level excipient · Every flag below links to the authority's published citation.

Supplement Facts

2 active ingredients
IngredientAmount% DV
Vitamin D3
Vitamin DvitaminUNII · 1C6V77QF41
UL · set4 effects
5 mcg25%
Calcium
mineralUNII · SY7Q814VUP
UL · set6 effects
500 mg38%
What this product supports · authorized claims

8 authority-backed effects

Rolled up from EFSA / FDA / NIH ODS authorized function claims on this product's active ingredients. Each row shows which ingredients contribute.

Flagged excipients

4 flagged · authority citations

  • ● AVOIDTitanium Dioxide
    color

    Banned in EU food products effective 2022-08 (Commission Regulation (EU) 2022/63) following EFSA Panel opinion that a safe daily intake could not be established due to genotoxicity concerns. Still GRAS in the US under 21 CFR 73.575 but EU position is stricter.

    eur-lex.europa.eu →efsa.europa.eu →ecfr.gov →
  • ◐ CAUTIONFD&C Yellow #5 Lake
    color

    EU requires warning label 'may have an adverse effect on activity and attention in children' per Commission Regulation 1333/2008 Annex III (following Southampton study 2007). FDA requires specific label declaration (21 CFR 74.705).

    eur-lex.europa.eu →ecfr.gov →
  • ◐ CAUTIONFD&C Blue #1
    color

    EU requires 'attention in children' warning per Commission Regulation 1333/2008 Annex III. Limited to specific food categories; capsule-shell use permitted with restrictions.

    eur-lex.europa.eu →
  • ◐ CAUTIONButylated Hydroxyanisole
    preservative

    Listed in NTP 15th Report on Carcinogens (2021) as 'reasonably anticipated to be a human carcinogen' based on sufficient evidence in experimental animals. Permitted in US food but with labeling requirements.

    ntp.niehs.nih.gov →ecfr.gov →
FDA CAERS · adverse event context
1
consumer-submitted adverse event reports filed with the FDA CFSAN Adverse Event Reporting System mentioning this product or its brand.

CAERS reports are unverified consumer submissions — not adjudicated causality. Large well-known brands accumulate proportionally more reports simply due to broader use. About CAERS →

Other ingredients

Maltodextrin · Microcrystalline Cellulose · Croscarmellose Sodium · Hypromellose · Starch · Magnesium Stearate · Stearic Acid · Butylated Hydroxyloluene · Coconut Oil · Triacetin · Propylene Glycol · Polyethylene Glycol

Chemically equivalent

Same formula, different brand

Products with identical sorted (ingredient, amount) tuples.