MedPath
FDA Product

CALMS FORTE

Product approved by U.S. Food and Drug Administration (US)

Basic Information

CALMS FORTE

54973-3257

Regulatory Information

54973-3257

April 9, 2025

Calms Forte

HUMAN OTC DRUG LABEL

10

Company Information

Hyland's Inc.

008316655

Active Ingredients

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

STARCH, TAPIOCA

Code: 24SC3U704I

Class Code: IACT

MAGNESIUM PALMITOSTEARATE

Code: R4OXA9G5BV

Class Code: IACT

FERROSOFERRIC PHOSPHATE

Quantity: 3 [hp_X] in 1 1

Code: 91GQH8I5F7

Class Code: ACTIB

POTASSIUM PHOSPHATE, DIBASIC

Quantity: 3 [hp_X] in 1 1

Code: CI71S98N1Z

Class Code: ACTIB

PASSIFLORA INCARNATA FLOWER

Quantity: 4 [hp_X] in 1 1

Code: K8F3G29S6Z

Class Code: ACTIB

SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

Quantity: 3 [hp_X] in 1 1

Code: 70WT22SF4B

Class Code: ACTIB

AVENA SATIVA FLOWERING TOP

Quantity: 4 [hp_X] in 1 1

Code: MA9CQJ3F7F

Class Code: ACTIB

LACTOSE, UNSPECIFIED FORM

Code: J2B2A4N98G

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

MATRICARIA RECUTITA

Quantity: 4 [hp_X] in 1 1

Code: G0R4UBI2ZZ

Class Code: ACTIB

HOPS

Quantity: 4 [hp_X] in 1 1

Code: 01G73H6H83

Class Code: ACTIB

MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE

Quantity: 3 [hp_X] in 1 1

Code: HF539G9L3Q

Class Code: ACTIB

TRIBASIC CALCIUM PHOSPHATE

Quantity: 3 [hp_X] in 1 1

Code: 91D9GV0Z28

Class Code: ACTIB

Active Moieties

AVENA SATIVA FLOWERING TOP

Code: MA9CQJ3F7F

PHOSPHATE ION

Code: NK08V8K8HR

MATRICARIA RECUTITA

Code: G0R4UBI2ZZ

FERROSOFERRIC PHOSPHATE

Code: 91GQH8I5F7

HOPS

Code: 01G73H6H83

MAGNESIUM CATION

Code: T6V3LHY838

PASSIFLORA INCARNATA FLOWER

Code: K8F3G29S6Z

© Copyright 2025. All Rights Reserved by MedPath