FDA.reportPublic FDA data

Chamomilla

Manufacturer
Hyland's Inc.
Effective date
2022-12-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:45:18

Label at a glance#

ProductChamomilla
Active ingredientMATRICARIA CHAMOMILLA
Label structure8 sections

Indications and uses

Temporarily relieves the symptoms of occasional sleeplessness, fussiness, and irritability

Dosage and administration

Children under 6 months of age: consult a licensed health care professional before using this product. Children 6 months to 2 years of age: dissolve 2 tablets under tongue every 15 minutes for 3 doses, then 2-3 times daily until relieved.

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Purpose

Chamomilla 6X HPUS

occasional sleeplessness, fussiness, and irritability

“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves the symptoms of occasional sleeplessness, fussiness, and irritability

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use:  • more than directed.  • if you have a known allergy to any ingredient in this product.

OTC - ASK DOCTOR SECTION

Consult a physician if symptoms persist for more than 7 days or worsen.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

OTC - DO NOT USE SECTION

Do not use if imprinted tamper band is broken or missing.

SPL UNCLASSIFIED SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Children under 6 months of age:

consult a licensed health care professional before using this product.

Children 6 months to 2 years of age:

dissolve 2 tablets under tongue every 15 minutes for 3 doses, then 2-3 times daily until

relieved.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose.

Questions or comments?

OTC - QUESTIONS SECTION

(800) 624-9659

OTC - PURPOSE SECTION

RELIEF OF OCCASIONAL SLEEPLESSNESS, FUSSINESS AND IRRITABILITY

PRINCIPAL DISPLAY PANEL - 125 TABLET BOTTLE CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New!

NDC 54973-3347-1

HOMEOPATHIC

SINCE 1903

Hyland's®

Baby

Natural

Relief

Comfort

Chamomilla

One Active Ingredient

RELIEF OF

OCCASIONAL

SLEEPLESSNESS,

FUSSINESS AND

IRRITABILITY*

No Artificial Flavors,

Dyes or Parabens

ACTUAL SIZE 65 MG

125 QUICK-DISSOLVING TABLETS

CartonCarton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-334754973-3347-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
ACACIA5C5403N26OIACT
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
32d9e106-9ab8-e8c7-e063-6394a90afb5f642ce868-c89d-7851-e053-2991aa0a6e062025-04-15WarningsExact identifier
spl set id: 642ce868-c89d-7851-e053-2991aa0a6e06

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.