Hyland's Naturals Baby Tiny Cold Tablets Daytime

Manufacturer: Hyland's Inc.
Effective date: 2024-11-21
Label type: HUMAN OTC DRUG LABEL
Version: 13
Source: full-release
Hydrated at: 2026-06-01 02:29:03

Label at a glance#

ProductTiny Cold

Active ingredientPOTASSIUM IODIDE, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT

Label structure9 sections

Indications and uses

■ Helps temporarily relieves symptoms of common cold in children, including: ■ runny nose or eyes ■ nasal congestion ■ headache ■ sneezing ■ cough

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. If symptoms persist, 2 tablets every 4 hours until relieved. Children 1 year to under 3 years At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours. If symptoms persist, 3 tablets every 4 hours until relieved.

Contacts and useful links#

PhoneLabel contact(800) 624-9659

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Relieves nasal congestion, runny nose, sneezing and cough

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

*Active ingredients*	*Purpose*
Eupatorium Perfoliatum 6X HPUS	headache, cough, sneezing
Euphrasia Officinalis 6X HPUS	runny eyes/nose
Gelsemium Sempervirens 6X HPUS	sneezing, nasal congestion
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

■ Helps temporarily relieves symptoms of common cold in children, including:

■ runny nose or eyes ■ nasal congestion ■ headache

■ sneezing ■ cough

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. If symptoms persist, 2 tablets every 4 hours until relieved.
Children 1 year to under 3 years	At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours. If symptoms persist, 3 tablets every 4 hours until relieved.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose

Questions?

OTC - QUESTIONS SECTION

(800) 624-9659

Indications and Usage Dosage and Administration

RECENT MAJOR CHANGES SECTION

 Temporarily relieves symptoms of common cold in children, including:

 runny nose or eyes  nasal congestion  headache  sneezing  cough

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. If symptoms persist,
2 tablets every 4 hours until relieved.
Children 1 year
to under 3 years
At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours. If symptoms persist,
3 tablets every 4 hours until relieved.

PRINCIPAL DISPLAY PANEL - Hyland's Baby Tiny Cold Tablets DAYTIME125 Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hyland's

•baby•

Tiny Cold

Tablets

DAYTIME

BCLD000T125CTNHN4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54973-3158-1	2023-07-27	C162847	48780-1	e4f33bdf-a218-d8a0-e053-dadaa90a6e4e	Hyland's Naturals Baby Tiny Cold Tablets Daytime
54973-3158-2	2023-07-27	C162847	48780-1	e4f33bdf-a218-d8a0-e053-dadaa90a6e4e	Hyland's Naturals Baby Tiny Cold Tablets Daytime
54973-3158-4	2023-07-27	C162847	48780-1	e4f33bdf-a218-d8a0-e053-dadaa90a6e4e	Hyland's Naturals Baby Tiny Cold Tablets Daytime
54973-3158-1	2022-07-29	C162847	48780-1	e4f33bdf-a218-d8a0-e053-dadaa90a6e4e	Hyland's Naturals Baby Tiny Cold Tablets Daytime
54973-3158-2	2022-07-29	C162847	48780-1	e4f33bdf-a218-d8a0-e053-dadaa90a6e4e	Hyland's Naturals Baby Tiny Cold Tablets Daytime
54973-3158-4	2022-07-29	C162847	48780-1	e4f33bdf-a218-d8a0-e053-dadaa90a6e4e	Hyland's Naturals Baby Tiny Cold Tablets Daytime

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54973-3158-1	Tiny Cold	1 in 1 CARTON	TABLET, SOLUBLE	1	13
54973-3158-1	Tiny Cold	125 in 1 BOTTLE, PLASTIC	TABLET, SOLUBLE	125	13
54973-3158-2	Tiny Cold	1 in 1 CARTON	TABLET, SOLUBLE	1	13
54973-3158-2	Tiny Cold	135 in 1 BOTTLE, PLASTIC	TABLET, SOLUBLE	135	13
54973-3158-4	Tiny Cold	6 in 1 PACKET	TABLET, SOLUBLE	6	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54973-3158	TINY COLD (EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE) TABLET, SOLUBLE [HYLAND'S INC.]	13	Current NDC, Legacy NDC, 5 package rows	20241123_7576bd5e-502e-4edf-99da-59cb1e97043f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
EUPATORIUM PERFOLIATUM FLOWERING TOP	ACTIVE INGREDIENT	1W0775VX6E	2
EUPHRASIA STRICTA	ACTIVE INGREDIENT	C9642I91WL	2
GELSEMIUM SEMPERVIRENS ROOT	ACTIVE INGREDIENT	639KR60Q1Q	2
POTASSIUM IODIDE	ACTIVE INGREDIENT	1C4QK22F9J	2
EUPATORIUM PERFOLIATUM FLOWERING TOP	ACTIVE MOIETY	1W0775VX6E	2
EUPHRASIA STRICTA	ACTIVE MOIETY	C9642I91WL	2
GELSEMIUM SEMPERVIRENS ROOT	ACTIVE MOIETY	639KR60Q1Q	2
IODIDE ION	ACTIVE MOIETY	09G4I6V86Q	2
ACACIA	INACTIVE INGREDIENT	5C5403N26O	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Tiny Cold
eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide
LACTOSE
POTASSIUM IODIDE
IODIDE ION
ACACIA
EUPATORIUM PERFOLIATUM FLOWERING TOP
EUPHRASIA STRICTA
GELSEMIUM SEMPERVIRENS ROOT

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54973-3158	54973-3158-1, 54973-3158-4, 54973-3158-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LACTOSE	J2B2A4N98G	IACT
POTASSIUM IODIDE	1C4QK22F9J	ACTIB
ACACIA	5C5403N26O	IACT
EUPATORIUM PERFOLIATUM FLOWERING TOP	1W0775VX6E	ACTIB
EUPHRASIA STRICTA	C9642I91WL	ACTIB
GELSEMIUM SEMPERVIRENS ROOT	639KR60Q1Q	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 132 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EXTENDED RELEASE / ORAL	400 mg		Exact identifier — unii+route 72 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CONCENTRATE / ORAL	NA		Exact identifier — unii+route 72 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EFFERVESCENT / ORAL	96.5 mg		Exact identifier — unii+route 72 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED PELLETS / ORAL	135.2 mg		Exact identifier — unii+route 72 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	CAPSULE, EXTENDED RELEASE / ORAL		64 mg	Exact identifier — unii+route 60 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED PELLETS / ORAL	135.2 mg		Exact identifier — unii+route 72 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	POWDER, FOR SUSPENSION / ORAL		7386 mg	Exact identifier — unii+route 60 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii+route 72 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii+route 72 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	CAPSULE, EXTENDED RELEASE / ORAL		64 mg	Exact identifier — unii+route 60 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii+route 60 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED / ORAL	590 mg		Exact identifier — unii+route 72 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, COATED / ORAL	332.05 mg		Exact identifier — unii+route 72 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		620 mg	Exact identifier — unii+route 72 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii+route 72 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii+route 60 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, COATED / ORAL	332.05 mg		Exact identifier — unii+route 72 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii+route 72 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, DELAYED RELEASE / ORAL	30 mg		Exact identifier — unii+route 60 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	POWDER, FOR SUSPENSION / ORAL		7386 mg	Exact identifier — unii+route 60 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / ORAL	530 mg		Exact identifier — unii+route 72 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	SUSPENSION / ORAL		2 mg	Exact identifier — unii+route 60 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CONCENTRATE / ORAL	NA		Exact identifier — unii+route 72 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, EXTENDED RELEASE / ORAL	120 mg		Exact identifier — unii+route 72 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	LOZENGE / ORAL		108 mg	Exact identifier — unii+route 60 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 72 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / ORAL	1682 mg/15ml		Exact identifier — unii+route 72 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, FILM COATED / ORAL	0.14 mg		Exact identifier — unii+route 60 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / ORAL	1682 mg/15ml		Exact identifier — unii+route 72 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CONCENTRATE / ORAL	NA		Exact identifier — unii+route 72 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, DELAYED RELEASE / ORAL	231.84 mg		Exact identifier — unii+route 72 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	SUSPENSION / ORAL		2 mg	Exact identifier — unii+route 60 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	CAPSULE, EXTENDED RELEASE / ORAL		64 mg	Exact identifier — unii+route 60 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, COATED / ORAL	156 mg		Exact identifier — unii+route 60 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	CAPSULE / ORAL		20 mg	Exact identifier — unii+route 60 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, FILM COATED / ORAL	0.14 mg		Exact identifier — unii+route 60 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, CHEWABLE / ORAL		1412 mg	Exact identifier — unii+route 72 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET / ORAL	70 mg		Exact identifier — unii+route 60 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii+route 72 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, COATED / ORAL	156 mg		Exact identifier — unii+route 60 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, COATED / ORAL	156 mg		Exact identifier — unii+route 60 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED PELLETS / ORAL	135.2 mg		Exact identifier — unii+route 72 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED / ORAL	590 mg		Exact identifier — unii+route 72 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	SUSPENSION / ORAL		2 mg	Exact identifier — unii+route 60 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii+route 60 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii+route 72 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EFFERVESCENT / ORAL	96.5 mg		Exact identifier — unii+route 72 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EXTENDED RELEASE / ORAL	400 mg		Exact identifier — unii+route 72 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, EXTENDED RELEASE / ORAL	34.4 mg		Exact identifier — unii+route 60 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii+route 72 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / ORAL	1682 mg/15ml		Exact identifier — unii+route 72 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	LOZENGE / ORAL		108 mg	Exact identifier — unii+route 60 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	SUSPENSION / ORAL		2 mg	Exact identifier — unii+route 60 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	POWDER, FOR SUSPENSION / ORAL		7386 mg	Exact identifier — unii+route 60 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 72 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	POWDER / ORAL	800 mg		Exact identifier — unii+route 60 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, EXTENDED RELEASE / ORAL	120 mg		Exact identifier — unii+route 72 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, CHEWABLE / ORAL		1412 mg	Exact identifier — unii+route 72 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii+route 60 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED / ORAL	590 mg		Exact identifier — unii+route 72 equally ranked IID candidates

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): 54973-3158-1 ndc11 (package): 54973315801
Tiny Cold	EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, AND POTASSIUM IODIDE	Hyland's Inc.	7576bd5e-502e-4edf-99da-59cb1e97043f	2024-11-21	Warnings	Exact identifier ndc (package): 54973-3158-2 ndc (package): 54973-3158-1 ndc (package): 54973-3158-4 ndc (product): 54973-3158 ndc11 (package): 54973315801 ndc11 (package): 54973315802 ndc11 (package): 54973315804 spl id: 27768618-c3fa-755c-e063-6394a90a82b6 spl set id: 7576bd5e-502e-4edf-99da-59cb1e97043f

Reported adverse events (FAERS/openFDA)#

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