Hyland's Naturals Baby Oral Pain Relief Nighttime

Drug Facts

Composition & Product

Active Ingredients

Oyster Shell Calcium Carbonate, Crude (12 [hp_X]) Phosphate Ion (30 [hp_X]) Matricaria Chamomilla (6 [hp_X]) Silicon Dioxide Arnica Montana Ferrosoferric Phosphate Arabica Coffee Bean Magnesium Cation

Inactive Ingredients

Anhydrous Lactose Acacia

Identifiers & Packaging

Pill Appearance

Shape: round Color: white Size: 9 mm Score: 1

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2017-08-17 Until 2021-12-27

Medication Information

Description

Active ingredients Purpose Arnica Montana 30X HPUS sore, sensitive or swelling gums Calcarea Carbonica 12X HPUS teething, sore, sensitive or swelling gums Calcarea Phosphorica 12X HPUS teething, sensitive, swelling gums, oral pain Chamomilla 12X HPUS sore, sensitive or swelling gums Coffea Cruda 6X HPUS oral pain, irritability Ferrum Phosphoricum 12X HPUS oral discomfort, swelling gums Magnesia Phosphorica 12X HPUS oral pain, occasional sleeplessness Silicea 12X HPUS oral pain at night, occasional sleeplessness "HPUS" is the Homeopathic Pharmacopoeia of the United States.

Uses

■ Helps temporarily relieve symptoms of oral pain or discomfort in children, including:

■ teething ■ gum sensitivity ■ swelling or soreness of gums

■ irritability ■ occasional sleeplessness

Section 55105-1

Helps temporarily relieve symptoms of oral pain or discomfort in children, including: teething, gum sensitivity, swelling or soreness of gums, irritability, occasional sleeplessness.

Section 55106-9

Active ingredients	Purpose
Arnica Montana 30X HPUS	sore, sensitive or swelling gums
Calcarea Carbonica 12X HPUS	teething, sore, sensitive or swelling gums
Calcarea Phosphorica 12X HPUS	teething, sensitive, swelling gums, oral pain
Chamomilla 12X HPUS	sore, sensitive or swelling gums
Coffea Cruda 6X HPUS	oral pain, irritability
Ferrum Phosphoricum 12X HPUS	oral discomfort, swelling gums
Magnesia Phosphorica 12X HPUS	oral pain, occasional sleeplessness
Silicea 12X HPUS	oral pain at night, occasional sleeplessness

"HPUS" is the Homeopathic Pharmacopoeia of the United States.

Directions

■ Use as directed.

Children under 6 months	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 6 months 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

Questions?

www.hylands.com or [email protected]

Inactive Ingredients

Acacia Gum, Lactose.

Principal Display Panel

Hyland's

NATURALS

•baby•

Oral Pain

Relief*

NIGHTTIME

NO BENZOCAINE,

DYES or PARABENS

Sleeplessness

Teething Pain

Oral Discomfort

Irritability

Swelling

0+ Months

125

QUICK-DISSOLVING TABLETS

HOMEOPATHIC

Stop Use and Ask A Doctor If

■ symptoms persist for more than 72 hours or worsen.

■ swelling increases; nasal congestion, rash or fever is present or develops.

■ irritation, pain or redness persists or worsens.

Structured Label Content

Uses

■ Helps temporarily relieve symptoms of oral pain or discomfort in children, including:

■ teething ■ gum sensitivity ■ swelling or soreness of gums

■ irritability ■ occasional sleeplessness

Section 55105-1 (55105-1)

Helps temporarily relieve symptoms of oral pain or discomfort in children, including: teething, gum sensitivity, swelling or soreness of gums, irritability, occasional sleeplessness.

Section 55106-9 (55106-9)

Active ingredients	Purpose
Arnica Montana 30X HPUS	sore, sensitive or swelling gums
Calcarea Carbonica 12X HPUS	teething, sore, sensitive or swelling gums
Calcarea Phosphorica 12X HPUS	teething, sensitive, swelling gums, oral pain
Chamomilla 12X HPUS	sore, sensitive or swelling gums
Coffea Cruda 6X HPUS	oral pain, irritability
Ferrum Phosphoricum 12X HPUS	oral discomfort, swelling gums
Magnesia Phosphorica 12X HPUS	oral pain, occasional sleeplessness
Silicea 12X HPUS	oral pain at night, occasional sleeplessness

"HPUS" is the Homeopathic Pharmacopoeia of the United States.

Directions

■ Use as directed.

Children under 6 months	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 6 months 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

Questions?

www.hylands.com or [email protected]

Inactive Ingredients (Inactive ingredients)

Acacia Gum, Lactose.

Principal Display Panel

Hyland's

NATURALS

•baby•

Oral Pain

Relief*

NIGHTTIME

NO BENZOCAINE,

DYES or PARABENS

Sleeplessness

Teething Pain

Oral Discomfort

Irritability

Swelling

0+ Months

125

QUICK-DISSOLVING TABLETS

HOMEOPATHIC

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ symptoms persist for more than 72 hours or worsen.

■ swelling increases; nasal congestion, rash or fever is present or develops.

■ irritation, pain or redness persists or worsens.

Advanced Ingredient Data

[{"name": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACACIA", "unii": "5C5403N26O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OYSTER SHELL CALCIUM CARBONATE, CRUDE", "unii": "2E32821G6I", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "PHOSPHATE ION", "unii": "NK08V8K8HR", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "MATRICARIA CHAMOMILLA", "unii": "G0R4UBI2ZZ", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "ARNICA MONTANA", "unii": "O80TY208ZW", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "FERROSOFERRIC PHOSPHATE", "unii": "91GQH8I5F7", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "ARABICA COFFEE BEAN", "unii": "3SW678MX72", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}, {"name": "MAGNESIUM CATION", "unii": "T6V3LHY838", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "■ Helps temporarily relieve symptoms of oral pain or discomfort in children, including: ■ teething ■ gum sensitivity ■ swelling or soreness of gums ■ irritability ■ occasional sleeplessness", "55105-1": "Helps temporarily relieve symptoms of oral pain or discomfort in children, including: teething, gum sensitivity, swelling or soreness of gums, irritability, occasional sleeplessness.", "55106-9": "Active ingredients Purpose Arnica Montana 30X HPUS sore, sensitive or swelling gums Calcarea Carbonica 12X HPUS teething, sore, sensitive or swelling gums Calcarea Phosphorica 12X HPUS teething, sensitive, swelling gums, oral pain Chamomilla 12X HPUS sore, sensitive or swelling gums Coffea Cruda 6X HPUS oral pain, irritability Ferrum Phosphoricum 12X HPUS oral discomfort, swelling gums Magnesia Phosphorica 12X HPUS oral pain, occasional sleeplessness Silicea 12X HPUS oral pain at night, occasional sleeplessness "HPUS" is the Homeopathic Pharmacopoeia of the United States.", "Directions": "■ Use as directed. Children under 6 months 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 6 months 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", "Questions?": "www.hylands.com or care@hylands.com", "Inactive ingredients": "Acacia Gum, Lactose.", "Principal Display Panel": "Hyland's NATURALS •baby• Oral Pain Relief* NIGHTTIM E NO BENZOCAINE, DYES or PARABENS Sleeplessness Teething Pain Oral Discomfort Irritability Swelling 0+ Months 125 QUICK-DISSOLVING TABLETS HOMEOPATHIC", "Stop use and ask a doctor if": "■ symptoms persist for more than 72 hours or worsen. ■ swelling increases; nasal congestion, rash or fever is present or develops. ■ irritation, pain or redness persists or worsens."}

Hyland's Naturals Baby Oral Pain Relief Nighttime

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information