Chamomilla

Manufacturer: Newton Laboratories, Inc.
Effective date: 2023-04-11
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:20:52

Label at a glance#

ProductChamomilla

Active ingredientMATRICARIA CHAMOMILLA

Label structure10 sections

Contacts and useful links#

PhoneLabel contact800.448.7256

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Teething pain; Diarrhea; Quarrelsome; Bad temper; Teething and colic

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth, (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.

OTC - ACTIVE INGREDIENT SECTION

Chamomilla 7x

OTC - PURPOSE SECTION

Teething pain; Diarrhea; Quarrelsome; Bad temper; Teething and colic

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

Warning:Keep out of reach of children. Do not use if tamper - evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55714-9021-6	Chamomilla	3 L in 1 BOTTLE, PLASTIC	LIQUID	3		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55714-9021	CHAMOMILLA LIQUID [NEWTON LABORATORIES, INC.]	1	Current NDC, 1 package rows	20230412_f912a32e-9bc9-c195-e053-6294a90a3e20.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

Chamomilla
WATER
ALCOHOL
MATRICARIA CHAMOMILLA

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55714-9021	55714-9021-6

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
Name	UNII	Kind
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT
MATRICARIA CHAMOMILLA	G0R4UBI2ZZ	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chamomilla	CHAMOMILLA	Newton Laboratories, Inc.	f912a32e-9bc9-c195-e053-6294a90a3e20	2023-04-11	Warnings	Exact identifier ndc (package): 55714-9021-6 ndc (product): 55714-9021 ndc11 (package): 55714902106 spl id: f912a363-35ba-8b6d-e053-6294a90a07eb spl set id: f912a32e-9bc9-c195-e053-6294a90a3e20

Reported adverse events (FAERS/openFDA)#

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