4 Kids Oral Pain Relief

4 Kids Oral Pain Relief
SPL v5
SPL
SPL Set ID 58ece525-b626-fa51-e053-2991aa0a35ef
Route
ORAL
Published
Effective Date 2017-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 9 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2017-08-18 Until 2021-12-16

Description

Active ingredients Purpose Arnica Montana 30X HPUS tooth pain, sensitive or swelling gums Calcarea Carbonica 12X HPUS tooth pain, sensitive gums or teeth Calcarea Phosphorica 12X HPUS sensitive gums or teeth, oral pain Chamomilla 12X HPUS tooth pain, sensitive gums or teeth Coffea Cruda 6X HPUS tooth pain, irritability Ferrum Phosphoricum 12X HPUS tooth pain, oral discomfort, swelling of gums “HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.


Medication Information

Warnings and Precautions

As with any drug, ask doctor before use if pregnant or breast-feeding.

Do not use • more than directed • if your child has a known allergy to any ingredient in this product.

Consult a physician if: • symptoms persist for more than 72 hours or worsen • swelling increases, rash or fever develops

• irritation, pain or redness persists or worsens.

Description

Active ingredients Purpose Arnica Montana 30X HPUS tooth pain, sensitive or swelling gums Calcarea Carbonica 12X HPUS tooth pain, sensitive gums or teeth Calcarea Phosphorica 12X HPUS sensitive gums or teeth, oral pain Chamomilla 12X HPUS tooth pain, sensitive gums or teeth Coffea Cruda 6X HPUS tooth pain, irritability Ferrum Phosphoricum 12X HPUS tooth pain, oral discomfort, swelling of gums “HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Uses

Temporarily relieves the symptoms of gum or tooth sensitivity, swelling of gums, tooth and oral pain and discomfort.

Section 50565-1

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

Section 50570-1

Do not use if imprinted tamper band is broken or missing.

Section 51727-6

Acacia Gum, Lactose.

Section 55105-1

Oral Pain Relief

Section 55106-9

Active ingredients

Purpose

Arnica Montana 30X HPUS

tooth pain, sensitive or swelling gums

Calcarea Carbonica 12X HPUS

tooth pain, sensitive gums or teeth

Calcarea Phosphorica 12X HPUS

sensitive gums or teeth, oral pain

Chamomilla 12X HPUS

tooth pain, sensitive gums or teeth

Coffea Cruda 6X HPUS

tooth pain, irritability

Ferrum Phosphoricum 12X HPUS

tooth pain, oral discomfort, swelling of gums

“HPUS” indicates that the active ingredients are in the official Homeopathic

Pharmacopœia of the United States.

Directions

Children 2 years to under 6 years of age: dissolve 2 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.

Children 6 years to under 12 years of age: dissolve 3 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.

Adults and Children 12 years and over: dissolve 4 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.

Hyland’s Oral Pain Relief Tablets are very soft and will dissolve instantly in the mouth.

In Case of Emergency

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.

Questions Or Comments?

(800) 624-9659

Principal Display Panel 125 Tablet Carton

New!

NDC 54973-3316-1

HOMEOPATHIC

Ages

2-12

Natural

Relief

SINCE 1903

Hyland's®

4 Kids

Oral Pain Relief

Toothache

Sensitive Teeth

Swelling Gums

Oral Disconfort

ACTUAL SIZE 65 MG

125 QUICK-DISSOLVING

TABLETS

SAFE &

EFFECTIVE


Structured Label Content

Uses

Temporarily relieves the symptoms of gum or tooth sensitivity, swelling of gums, tooth and oral pain and discomfort.

Warnings and Precautions (34071-1)

As with any drug, ask doctor before use if pregnant or breast-feeding.

Do not use • more than directed • if your child has a known allergy to any ingredient in this product.

Consult a physician if: • symptoms persist for more than 72 hours or worsen • swelling increases, rash or fever develops

• irritation, pain or redness persists or worsens.

Section 50565-1 (50565-1)

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

Section 50570-1 (50570-1)

Do not use if imprinted tamper band is broken or missing.

Section 51727-6 (51727-6)

Acacia Gum, Lactose.

Section 55105-1 (55105-1)

Oral Pain Relief

Section 55106-9 (55106-9)

Active ingredients

Purpose

Arnica Montana 30X HPUS

tooth pain, sensitive or swelling gums

Calcarea Carbonica 12X HPUS

tooth pain, sensitive gums or teeth

Calcarea Phosphorica 12X HPUS

sensitive gums or teeth, oral pain

Chamomilla 12X HPUS

tooth pain, sensitive gums or teeth

Coffea Cruda 6X HPUS

tooth pain, irritability

Ferrum Phosphoricum 12X HPUS

tooth pain, oral discomfort, swelling of gums

“HPUS” indicates that the active ingredients are in the official Homeopathic

Pharmacopœia of the United States.

Directions

Children 2 years to under 6 years of age: dissolve 2 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.

Children 6 years to under 12 years of age: dissolve 3 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.

Adults and Children 12 years and over: dissolve 4 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.

Hyland’s Oral Pain Relief Tablets are very soft and will dissolve instantly in the mouth.

In Case of Emergency (In case of emergency)

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.

Questions Or Comments? (Questions or comments?)

(800) 624-9659

Principal Display Panel 125 Tablet Carton (PRINCIPAL DISPLAY PANEL - 125 TABLET CARTON)

New!

NDC 54973-3316-1

HOMEOPATHIC

Ages

2-12

Natural

Relief

SINCE 1903

Hyland's®

4 Kids

Oral Pain Relief

Toothache

Sensitive Teeth

Swelling Gums

Oral Disconfort

ACTUAL SIZE 65 MG

125 QUICK-DISSOLVING

TABLETS

SAFE &

EFFECTIVE


Advanced Ingredient Data


Raw Label Data

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