Baby Colic Tablets

Manufacturer: Hyland's Inc. | Hyland's Inc
Effective date: 2022-11-28
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: legacy-cache
Hydrated at: 2026-08-01 21:46:05

Label at a glance#

ProductBABY COLIC

Active ingredientDIOSCOREA VILLOSA TUBER, CHAMOMILE, CITRULLUS COLOCYNTHIS FRUIT PULP

Label structure12 sections

Indications and uses

■ Temporarily relieves symptoms associated with colic in children, including: ■ gas pain ■ irritability ■ restlessness

Dosage and administration

Children under 3 years Dissolve 2 tablets on tongue every 15 minutes up to 8 doses, then every 2 hours until relieved. Hyland's Baby Colic Tablets are very soft and will dissolve instantly in the mouth.

Contacts and useful links#

PhoneLabel contact(800) 624-9659

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Relieves colic, gas pain and fussiness

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredients	Purpose
Chamomilla 6X HPUS	restlessness, irritability
Colocynthis 6X HPUS	abdominal pain associated with gas
Dioscorea 6X HPUS	colic pains better from motion

SPL UNCLASSIFIED SECTION

Hyland's Baby Colic Tablets are very soft and will dissolve instantly

in the mouth.

Uses

INDICATIONS & USAGE SECTION

■ Temporarily relieves symptoms associated with colic in children, including:

■ gas pain ■ irritability ■ restlessness

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use more than directed.

OTC - ASK DOCTOR SECTION

Consult a physician if symptoms persist for more than 72 hours or worsen .

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of the reach of children.

OVERDOSAGE SECTION

In case of emergency or accidental overdose, 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

3 years

Dissolve 2 tablets on tongue every 15 minutes

up to 8 doses, then every 2 hours until relieved.

SPL UNCLASSIFIED SECTION

Hyland's Baby Colic Tablets are very soft and will dissolve instantly in the mouth.

Other information

OTHER SAFETY INFORMATION

■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.

■ The inner packaged bottle is child-resistant.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose

Questions or comments?

OTC - QUESTIONS SECTION

(800) 624-9659

SPL UNCLASSIFIED SECTION

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE,

NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

Indications and Usage ( Uses)

RECENT MAJOR CHANGES SECTION

■ Temporarily relieves symptoms associated with colic in children, including:

■ gas pain ■ irritability ■ restlessness

Dosage and Administration ( Directions)

RECENT MAJOR CHANGES SECTION

Children under

3 years

Dissolve 2 tablets on tongue every 15 minutes

up to 8 doses, then every 2 hours until relieved.

Hyland's Baby Colic Tablets are very soft and will dissolve instantly in the mouth.

PRINCIPAL DISPLAY PANEL - 125 Tablet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HOMEOPATHIC

NDC 54973-3147-1

months

NEW

LOOK

BABY

SINCE 1903
Hyland's

Colic
Tablets*

Relieves colic, gas pain

and fussiness

NO ARTIFICIAL FLAVORS

NO DYES or PARABENS

NATURAL

RELIEF

125 QUICK- DISSOLVING

TABLETS

*SEE NOTE ON BACK

PANEL BELOW DRUG FACTS

carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CHAMOMILE	ACTIVE INGREDIENT	FGL3685T2X	1
CITRULLUS COLOCYNTHIS FRUIT PULP	ACTIVE INGREDIENT	23H32AOH17	1
DIOSCOREA VILLOSA TUBER	ACTIVE INGREDIENT	IWY3IWX2G8	1
CHAMOMILE	ACTIVE MOIETY	FGL3685T2X	1
CITRULLUS COLOCYNTHIS FRUIT PULP	ACTIVE MOIETY	23H32AOH17	1
DIOSCOREA VILLOSA TUBER	ACTIVE MOIETY	IWY3IWX2G8	1
ACACIA	INACTIVE INGREDIENT	5C5403N26O	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

BABY COLIC
dioscorea villosa tuber, chamomile, and citrullus colocynthis fruit pulp
LACTOSE, UNSPECIFIED FORM
ACACIA
DIOSCOREA VILLOSA TUBER
CHAMOMILE
CITRULLUS COLOCYNTHIS FRUIT PULP

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54973-3147	54973-3147-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LACTOSE, UNSPECIFIED FORM	J2B2A4N98G	IACT
ACACIA	5C5403N26O	IACT
DIOSCOREA VILLOSA TUBER	IWY3IWX2G8	ACTIB
CHAMOMILE	FGL3685T2X	ACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP	23H32AOH17	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 1 · 55 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, DELAYED RELEASE / ORAL		160 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EXTENDED RELEASE / ORAL	400 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED PELLETS / ORAL	135.2 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / SUBLINGUAL		352 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	FILM, EXTENDED RELEASE / TRANSDERMAL	675 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER / VAGINAL	430 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, FILM COATED / ORAL	0.14 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, EXTENDED RELEASE / ORAL	120 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION / INTRAMUSCULAR	203.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / RECTAL	20 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / ORAL	530 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	SUSPENSION / ORAL		2 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		620 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET / ORAL	70 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / RECTAL	8 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / ORAL	1682 mg/15ml		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, ORALLY DISINTEGRATING / ORAL		7 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	CAPSULE / ORAL		20 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, DELAYED RELEASE / ORAL	231.84 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / BUCCAL	296.7 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	193.8 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	SUSPENSION / INTRAMUSCULAR	1 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	POWDER / ORAL	800 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	GUM, CHEWING / BUCCAL		280 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED / ORAL	590 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION / INTRAVENOUS	203.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CREAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER / RESPIRATORY (INHALATION)	90 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, CHEWABLE / ORAL		1412 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	SYRUP / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET / SUBLINGUAL	9.1 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, DELAYED RELEASE / ORAL	30 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	LOZENGE / ORAL		108 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, EXTENDED RELEASE / ORAL	34.4 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EFFERVESCENT / ORAL	96.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, COATED / ORAL	156 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	POWDER, FOR SUSPENSION / ORAL		7386 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	CAPSULE, EXTENDED RELEASE / ORAL		64 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, CHEWABLE / ORAL		121 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	GRANULE, FOR SUSPENSION / ORAL	512.5 mg/5ml		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, SOLUTION / INTRAVENOUS	0.45 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / RESPIRATORY (INHALATION)	44.4 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, COATED / ORAL	332.05 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET / BUCCAL	9.1 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 36 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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
0812cec1-1e75-f541-e063-6394a90aeca0			675b4db6-2d77-4bb2-a153-9d522abb2df2	2023-10-19	Warnings	Exact identifier spl set id: 675b4db6-2d77-4bb2-a153-9d522abb2df2

Reported adverse events (FAERS/openFDA)#

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