Hyland's Naturals Baby Calming

SPL v5

SPL

SPL Set ID 8f20251b-111b-4b7b-8098-4371d04004bd

Route

ORAL

Published

Effective Date 2021-10-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Matricaria Recutita (6 [hp_X]) Arabica Coffee Bean (30 [hp_X]) Strychnos Ignatii Seed (12 [hp_X]) Lycopodium Clavatum Spore Sodium Cation Platinum Anemone Pulsatilla Sulfur

Inactive Ingredients

Acacia Lactose, Unspecified Form

Identifiers & Packaging

Pill Appearance

Shape: round Color: white Size: 5 mm Score: 1

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2017-01-20 Until 2021-12-20

Description

Drug Facts

Indications and Usage

■ Temporarily relieves symptoms of irritability or restlessness in children, including: ■ occasional sleeplessness ■ fussiness ■ agitation ■ restless sleep ■ unpredictable or irregular sleep ■ waking at night ■ crying ■ inconsolable behavior

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.

Medication Information

Indications and Usage

■ Temporarily relieves symptoms of irritability or restlessness in children, including:

■ occasional sleeplessness ■ fussiness ■ agitation

■ restless sleep ■ unpredictable or irregular sleep ■ waking at night

■ crying ■ inconsolable behavior

Dosage and Administration

Description

Drug Facts

Uses

■ Temporarily relieves symptoms of irritability or restlessness in children, including:

■ occasional sleeplessness ■ fussiness ■ agitation

■ restless sleep ■ unpredictable or irregular sleep ■ waking at night

■ crying ■ inconsolable behavior

Section 42229-5

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE,

NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

Section 50565-1

Keep out of reach of children.

Section 50569-3

Stop use and ask a doctor if: ■ symptoms persist for more than 72 hours or worsen.

■ symptoms are accompanied by a fever.

Section 55105-1

Active ingredients	Purpose
"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Chamomilla 6X HPUS	occasional sleeplessness, fussiness, and agitation
Coffea Cruda 6X HPUS	irritability
Ignatia Amara 30X HPUS (less than 0.0000000000001% Alkaloids, calculated)	restless sleep
Lycopodium 30X HPUS	unpredictable, irregular sleep
Natrum Muriaticum 6X HPUS	crying, irritability
Platinum Metallicum 30X HPUS	causeless crying, waking at night
Pulsatilla 6X HPUS	cries easily, inconsolable
Sulphur 12X HPUS	crying, restlessness, irritability

Section 60561-8

DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

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.

Drug Facts

Drug Facts

Inactive Ingredients

Acacia Gum, Lactose.

Questions Or Comments?

www.hylands.com or (800) 624-9659

Dosage and Administration (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.

Package Label Principal Display Panel

Hyland's

Naturals™

•baby•

Calming

Tablets*

NO ARTIFICIAL FLAVORS,

DYES or PARABENS

Sleeplessness

Fussiness

Irritability

6+ MONTHS

125

QUICK-DISSOLVING TABLETS

HOMEOPATHIC

Structured Label Content

Uses

■ Temporarily relieves symptoms of irritability or restlessness in children, including:

■ occasional sleeplessness ■ fussiness ■ agitation

■ restless sleep ■ unpredictable or irregular sleep ■ waking at night

■ crying ■ inconsolable behavior

Section 42229-5 (42229-5)

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE,

NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50569-3 (50569-3)

Stop use and ask a doctor if: ■ symptoms persist for more than 72 hours or worsen.

■ symptoms are accompanied by a fever.

Section 55105-1 (55105-1)

Active ingredients	Purpose
"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Chamomilla 6X HPUS	occasional sleeplessness, fussiness, and agitation
Coffea Cruda 6X HPUS	irritability
Ignatia Amara 30X HPUS (less than 0.0000000000001% Alkaloids, calculated)	restless sleep
Lycopodium 30X HPUS	unpredictable, irregular sleep
Natrum Muriaticum 6X HPUS	crying, irritability
Platinum Metallicum 30X HPUS	causeless crying, waking at night
Pulsatilla 6X HPUS	cries easily, inconsolable
Sulphur 12X HPUS	crying, restlessness, irritability

Section 60561-8 (60561-8)

DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

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.

Drug Facts

Drug Facts

Inactive Ingredients (Inactive ingredients)

Acacia Gum, Lactose.

Indications and Usage

■ Temporarily relieves symptoms of irritability or restlessness in children, including:

■ occasional sleeplessness ■ fussiness ■ agitation

■ restless sleep ■ unpredictable or irregular sleep ■ waking at night

■ crying ■ inconsolable behavior

Questions Or Comments? (Questions or comments?)

www.hylands.com or (800) 624-9659

Dosage and Administration (directions) (Dosage and Administration (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.

Package Label Principal Display Panel (PACKAGE LABEL - PRINCIPAL DISPLAY PANEL)

Hyland's

Naturals™

•baby•

Calming

Tablets*

NO ARTIFICIAL FLAVORS,

DYES or PARABENS

Sleeplessness

Fussiness

Irritability

6+ MONTHS

125

QUICK-DISSOLVING TABLETS

HOMEOPATHIC

Advanced Ingredient Data

[{"name": "ACACIA", "unii": "5C5403N26O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE, UNSPECIFIED FORM", "unii": "J2B2A4N98G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MATRICARIA RECUTITA", "unii": "G0R4UBI2ZZ", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "ARABICA COFFEE BEAN", "unii": "3SW678MX72", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "STRYCHNOS IGNATII SEED", "unii": "1NM3M2487K", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "LYCOPODIUM CLAVATUM SPORE", "unii": "C88X29Y479", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "SODIUM CATION", "unii": "LYR4M0NH37", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "PLATINUM", "unii": "49DFR088MY", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "ANEMONE PULSATILLA", "unii": "I76KB35JEV", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "SULFUR", "unii": "70FD1KFU70", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "■ Temporarily relieves symptoms of irritability or restlessness in children, including: ■ occasional sleeplessness ■ fussiness ■ agitation ■ restless sleep ■ unpredictable or irregular sleep ■ waking at night ■ crying ■ inconsolable behavior", "42229-5": "*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.", "50565-1": "Keep out of reach of children.", "50569-3": "Stop use and ask a doctor if: ■ symptoms persist for more than 72 hours or worsen. ■ symptoms are accompanied by a fever.", "55105-1": "Active ingredients Purpose "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States. Chamomilla 6X HPUS occasional sleeplessness, fussiness, and agitation Coffea Cruda 6X HPUS irritability Ignatia Amara 30X HPUS (less than 0.0000000000001% Alkaloids, calculated) restless sleep Lycopodium 30X HPUS unpredictable, irregular sleep Natrum Muriaticum 6X HPUS crying, irritability Platinum Metallicum 30X HPUS causeless crying, waking at night Pulsatilla 6X HPUS cries easily, inconsolable Sulphur 12X HPUS crying, restlessness, irritability", "60561-8": "DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.", "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.", "Drug Facts": "Drug Facts", "Inactive ingredients": "Acacia Gum, Lactose.", "Indications and Usage": "■ Temporarily relieves symptoms of irritability or restlessness in children, including: ■ occasional sleeplessness ■ fussiness ■ agitation ■ restless sleep ■ unpredictable or irregular sleep ■ waking at night ■ crying ■ inconsolable behavior", "Questions or comments?": "www.hylands.com or (800) 624-9659", "Dosage and Administration (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.", "PACKAGE LABEL - PRINCIPAL DISPLAY PANEL": "Hyland's Naturals™ •baby• Calming Tablets* NO ARTIFICIAL FLAVORS, DYES or PARABENS Sleeplessness Fussiness Irritability 6+ MONTHS 125 QUICK-DISSOLVING TABLETS HOMEOPATHIC"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:10:04.575749 · Updated: 2026-03-14T23:15:14.298659