Bayer

Alka-Seltzer Extra Strength Heartburn Relief Chews Assorted Fruit

Serving
1 Tablet(s)
Form
tablet
UPC
016500563815
DSLD
Avoid-flaggedObjective label signals
Flagged excipients
5
1 avoid · 4 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

1 active ingredients
IngredientAmount% DV
Calcium Carbonate
CalciumUNII · H0G9379FGK
750 mg
Flagged excipients

5 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.

  • ◐ CAUTIONFD&C Red #40 Aluminum Lake
    color

    EU requires the same 'attention/activity in children' warning label as Yellow 5 per Commission Regulation 1333/2008 Annex III. California enacted a public-school ban effective 2028 (AB 2316, 2024).

  • ◐ 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).

  • ◐ CAUTIONMethyl Paraben
    preservative

    EFSA 2004 re-evaluation (EFSA Journal 83) found propylparaben could not have an ADI established. EU banned propylparaben as food additive (Commission Regulation 1333/2008 Annex II removed it). US still permits.

  • ◐ CAUTIONPropyl Paraben
    preservative

    EFSA 2004 re-evaluation (EFSA Journal 83) found propylparaben could not have an ADI established. EU banned propylparaben as food additive (Commission Regulation 1333/2008 Annex II removed it). US still permits.

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

Acacia · Carmine · Carnauba Wax · Citric Acid · Corn Starch · Corn Syrup · DL-Alpha-Tocopherol · FD&C Blue #1 Aluminum Lake · FD&C Yellow #6 · FD&C Yellow #6 Aluminum Lake · FD&C Yellow #6 Lake · Flavors · hydrogenated Coconut Oil · Hydrogenated Vegetable Oil · Lecithin · Medium Chain Triglycerides · modified Starch · Phosphoric Acid · pregelatinized modified Starch · Propylene Glycol · Shellac · Sodium Benzoate · Sorbic Acid · Sorbitol · Sugar · Water · White Wax