Home FDA labels ef42fef9-4849-0874-e053-2a95a90a4e80 CALMS FORTE openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)
Brand name CALMS FORTE
Generic name AVENA SATIVA FLOWERING TOP, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA RECUTITA, FERROSOFERRIC PHOSPHATE, HOPS, POTASSIUM PHOSPHATE, DIBASIC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, AND PASSIFLORA INCARNATA FLOWER
Manufacturer Hyland's Inc.
Product type HUMAN OTC DRUG
SPL set ID f48a35d4-aa0c-48b1-a2ad-a614ea2894e8
SPL ID ef42fef9-4849-0874-e053-2a95a90a4e80
Version 3
Effective date 2022-12-07
Source export date 2026-09-28
Source partition 4
Source file https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 05:26:36 Harmonized routes table Harmonized routes ORAL
Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 17 matching rows.
Type, Scope, Identifier table Type Scope Identifier Source field brand name CALMS FORTE openfda.brand_name generic name AVENA SATIVA FLOWERING TOP, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA RECUTITA, FERROSOFERRIC PHOSPHATE, HOPS, POTASSIUM PHOSPHATE, DIBASIC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, AND PASSIFLORA INCARNATA FLOWER openfda.generic_name manufacturer name Hyland's Inc. openfda.manufacturer_name ndc package 54973-3274-1 openfda.package_ndc ndc product 54973-3274 openfda.product_ndc ndc11 package 54973327401 derived:openfda.package_ndc spl id ef42fef9-4849-0874-e053-2a95a90a4e80 id spl set id f48a35d4-aa0c-48b1-a2ad-a614ea2894e8 set_id unii CI71S98N1Z openfda.unii unii 91D9GV0Z28 openfda.unii unii HF539G9L3Q openfda.unii unii 91GQH8I5F7 openfda.unii unii 01G73H6H83 openfda.unii unii MA9CQJ3F7F openfda.unii unii G0R4UBI2ZZ openfda.unii unii K8F3G29S6Z openfda.unii unii 70WT22SF4B openfda.unii
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings Warnings As with any drug, ask a doctor before use if pregnant or breast-feeding. Consult a physician if symptoms persist for more than 7 days. Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately. Do not use if imprinted tamper band is broken or missing. In case of emergency, contact a medical professional or Poison Control Center immediately. Hyland's may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.