Hyland's Naturals Baby Oral Pain Relief Daytime

Hyland's Naturals Baby Oral Pain Relief Daytime
SPL v15
SPL
SPL Set ID 5904f126-e8f0-a892-e053-2991aa0aef0f
Route
ORAL
Published
Effective Date 2023-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oyster Shell Calcium Carbonate, Crude (12 [hp_X]) Phosphate Ion (6 [hp_X]) Arabica Coffee Bean (30 [hp_X]) Arnica Montana Matricaria Chamomilla Ferrum Phosphoricum
Inactive Ingredients
Acacia Anhydrous Lactose

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 5 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2017-08-17 Until 2021-12-27
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 "HPUS" is the Homeopathic Pharmacopoeia of the United States.

Indications and Usage

Uses* Removed *

Medication Information

Indications and Usage

Uses*

Removed *

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 "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

Section 55105-1

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

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

"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. If symptoms persist,

2 tablets every 4 hours until relieved.
Children 6 months

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.

Questions?

www.hylands.com or [email protected]

Inactive Ingredients

Acacia Gum, Lactose.

Principal Display Panel

Hyland's

NATURALS™

•baby•

Oral Pain

Relief*

DAYTIME

NO BENZOCAINE,

DYES or PARABENS

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

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

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

"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. If symptoms persist,

2 tablets every 4 hours until relieved.
Children 6 months

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.

Questions?

www.hylands.com or [email protected]

Inactive Ingredients (Inactive ingredients)

Acacia Gum, Lactose.

Indications and Usage

Uses*

Removed *

Principal Display Panel

Hyland's

NATURALS™

•baby•

Oral Pain

Relief*

DAYTIME

NO BENZOCAINE,

DYES or PARABENS

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

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:11:56.992003 · Updated: 2026-03-14T23:17:15.281880