Hyland's Naturals Baby Tiny Cold Tablets Nighttime

Manufacturer: Hyland's | Standard Homeopathic Company | Merical, Inc.
Effective date: 2021-12-27
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 02:15:15

Label at a glance#

ProductBaby Nighttime Tiny Cold

Active ingredientMATRICARIA RECUTITA, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM IODIDE

Label structure9 sections

Indications and uses

■ Temporarily relieves symptoms of common cold in children at night, including: ■ runny nose or eyes ■ cough ■ nasal congestion ■ headache ■ sneezing ■ occasional sleeplessness

Dosage and administration

■ Use as directed. Children under 6 months Ask a doctor before use. Children 6 months to under 1 year At onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours as needed. If symptoms persist, 2 tablets every 4 hours during the night until relieved. Children 1 year to under 3 years At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours as needed. If symptoms persist, 3 tablets...

Contacts and useful links#

PhoneLabel contact(800) 624-9659

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Relieves nasal congestion, runny nose, sneezing, cough and occasional sleeplessness

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

*Active ingredients*	*Purpose*
Chamomilla 6X HPUS	occasional sleeplessness
Eupatorium Perfoliatum 6X HPUS	headache, cough, sneezing
Euphrasia Officinalis 6X HPUS	runny eyes/nose, nighttime coughing
Gelsemium Sempervirens 6X HPUS	sneezing, nasal congestion,occasional sleeplessness
Kali Iodatum 6X HPUS	headache, runny eyes/nose

"HPUS" indicates that the active ingredients are in the official Homeopathic

Pharmacopoeia of the United States.

Uses

INDICATIONS & USAGE SECTION

■ Temporarily relieves symptoms of common cold in children at night, including:

■ runny nose or eyes ■ cough ■ nasal congestion

■ headache ■ sneezing ■ occasional sleeplessness

Warnings

WARNINGS SECTION

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

■ persistent or chronic cough such as asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if:

OTC - DO NOT USE SECTION

■ symptoms persist for more than 72 hours or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

■ Use as directed.

Children under 6 months	Ask a doctor before use.
Children 6 months to under 1 year	At onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours as needed. If symptoms persist, 2 tablets every 4 hours during the night until relieved.
Children 1 year to under 3 years	At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours as needed. If symptoms persist, 3 tablets every 4 hours during the night until relieved.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose.

Questions?

OTC - QUESTIONS SECTION

(800) 624-9659

Indications and Usage ( Uses) Dosage and Administration

RECENT MAJOR CHANGES SECTION

■ Temporarily relieves symptoms of common cold in children at night, including:

■ runny nose or eyes ■ cough ■ nasal congestion

■ headache ■ sneezing ■ occasional sleeplessness

Directions

■ Use as directed.

Children under 6 months
Ask a doctor before use.
Children 6 months
to under 1 year
At onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours as needed. If symptoms persist,
2 tablets every 4 hours during the night until relieved.
Children 1 year
to under 3 years
At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours as needed. If symptoms persist,
3 tablets every 4 hours during the night until relieved.

PRINCIPAL DISPLAY PANEL - 125 Tablet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hyland's

NATURALS™

•baby•

Tiny Cold

Tablets*

Nighttime

NO ARTIFICIAL FLAVORS,

DYES or PARABENS

Sleeplessness

Nasal Congestions

Runny Nose

Sneezing

Cough

6+ MONTHS

125

QUICK-DISSOLVING TABLETS

HOMEOPATHIC

carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54973-3252-1	2022-07-29	C162847	48780-1	e4f33bdf-9c53-d8a0-e053-dadaa90a6e4e	Hyland's Naturals Baby Tiny Cold Tablets Nighttime
54973-3252-2	2022-07-29	C162847	48780-1	e4f33bdf-9c53-d8a0-e053-dadaa90a6e4e	Hyland's Naturals Baby Tiny Cold Tablets Nighttime

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54973-3252-1	Baby Nighttime Tiny Cold	125 in 1 BOTTLE, PLASTIC	TABLET	125	8
54973-3252-1	Baby Nighttime Tiny Cold	1 in 1 CARTON	TABLET	1	8
54973-3252-2	Baby Nighttime Tiny Cold	6 in 1 PACKET	TABLET	6	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54973-3252	BABY NIGHTTIME TINY COLD (MATRICARIA RECUTITA, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) TABLET [HYLAND'S]	8	Legacy NDC, 3 package rows	20211228_275f18d5-739e-4055-9553-10ae2be836ad.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Baby Nighttime Tiny Cold
matricaria recutita, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide
ACACIA
LACTOSE, UNSPECIFIED FORM
MATRICARIA RECUTITA
EUPATORIUM PERFOLIATUM FLOWERING TOP
EUPHRASIA STRICTA
GELSEMIUM SEMPERVIRENS ROOT
POTASSIUM IODIDE
IODIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54973-3252	54973-3252-1, 54973-3252-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACACIA	5C5403N26O	IACT
LACTOSE, UNSPECIFIED FORM	J2B2A4N98G	IACT
MATRICARIA RECUTITA	G0R4UBI2ZZ	ACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOP	1W0775VX6E	ACTIB
EUPHRASIA STRICTA	C9642I91WL	ACTIB
GELSEMIUM SEMPERVIRENS ROOT	639KR60Q1Q	ACTIB
POTASSIUM IODIDE	1C4QK22F9J	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baby Tiny Cold Daytime and Nighttime	EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM IODIDE, AND MATRICARIA RECUTITA	Hyland's Inc.	be7cff09-ecff-48bd-96d4-dc7d47db7656	2026-08-20	Warnings	Exact identifier ndc (package): 54973-3252-1 ndc11 (package): 54973325201
d42742f0-697a-ba1a-e053-2a95a90aa786			275f18d5-739e-4055-9553-10ae2be836ad	2021-12-27	Warnings	Exact identifier spl id: d42742f0-697a-ba1a-e053-2a95a90aa786 spl set id: 275f18d5-739e-4055-9553-10ae2be836ad

Reported adverse events (FAERS/openFDA)#

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