4 Kids Earache Relief

4 Kids Earache Relief
SPL v5
SPL
SPL Set ID 7ee2a9f8-4a16-4a9d-e053-2a91aa0a1be7
Route
AURICULAR (OTIC)
Published
Effective Date 2019-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Atropa Belladonna (30 [hp_C]) Oyster Shell Calcium Carbonate, Crude Matricaria Chamomilla Anemone Pulsatilla Sulfur Lycopodium Clavatum Spore
Inactive Ingredients
Water Citric Acid Monohydrate Glycerin Sodium Benzoate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-03-01

Description

Relieves earache due to swimmer’s ear, cold, flu & allergy

Indications and Usage

Temporarily relieves symptoms of earache in children, including: ■ minor fever ■ ear pain or throbbing ■ common pain or itching of "swimmer’s ear" ■ irritability or occasional sleeplessness associated with earaches after diagnosis by a physician

Purpose

Relieves earache due to swimmer’s ear, cold, flu & allergy

Dosage and Administration

■ Shake well before using. Children ages 2 years and over: Tilt head sideways and apply 3-4 drops into involved ear (Tip of applicator should not enter ear canal). Keep head tilted for at least 2 minutes to keep drops in ear. Repeat until relieved, up to 4 times daily.


Medication Information

Indications and Usage

Temporarily relieves symptoms of earache in children, including: ■ minor fever ■ ear pain or throbbing ■ common pain or itching of "swimmer’s ear" ■ irritability or occasional sleeplessness associated with earaches after diagnosis by a physician

Purpose

Relieves earache due to swimmer’s ear, cold, flu & allergy

Dosage and Administration

■ Shake well before using. Children ages 2 years and over: Tilt head sideways and apply 3-4 drops into involved ear (Tip of applicator should not enter ear canal). Keep head tilted for at least 2 minutes to keep drops in ear. Repeat until relieved, up to 4 times daily.

Description

Relieves earache due to swimmer’s ear, cold, flu & allergy

Uses

Temporarily relieves symptoms of earache in children, including: ■ minor fever ■ ear pain or throbbing ■ common pain or

itching of "swimmer’s ear" ■ irritability or occasional sleeplessness associated with earaches after diagnosis by a physician

Section 42229-5

"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Section 50565-1

Keep this and all medications out of the reach of children. If swallowed, 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.

Section 50568-5

Consult a physician if: ■ symptoms persist for more than 48 hours or worsen. ■ discharge from ear is present. ■ symptoms are accompanied by a high fever (over 101°F).

Section 50570-1

Do not use if you have ear tubes, damaged ear drums or after ear surgery.

Section 53414-9

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

Section 55106-9

Active ingredients

Purpose

Belladonna 30C HPUS

(less than 0.000000000001% Alkaloids, calculated)

minor fever

Calcarea Carbonica 30C HPUS

throbbing ear pain

Chamomilla 30C HPUS

occasional sleeplessness and irritability

Lycopodium 30C HPUS

ear pain

Pulsatilla 30C HPUS

ear itching, pain worse at night

Sulphur 30C HPUS

ear pain with burning

Warnings

Keep away from eyes. Do not take by mouth.

Earache drops are only to be used in ears.

Directions

■ Shake well before using.

Children ages 2 years and over: Tilt head sideways and apply 3-4 drops into involved ear (Tip of applicator should not enter ear canal). Keep head tilted for at least 2 minutes to keep drops in ear. Repeat until relieved, up to 4 times daily.

Other Information

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

■ Store at room temperature.

■ Do not refrigerate.

Inactive Ingredients

Citric Acid, Glycerine, Purified Water, Sodium Benzoate.

Questions Or Comments?

(800) 624-9659

Principal Display Panel

HOMEOPATHIC

NDC 54973-3392-1

2-12

YEARS

NEW

LOOK

4 KIDS

SINCE 1903

Hyland's

Earache

Relief*

Relieves earache

due to swimmer’s ear,

cold, flu & allergy

NO DYES or PARABENS

NO NUMBING EFFECT

NATURAL

RELIEF*

0.33 FL. OZ. (10 mL)

*SEE NOTE ON SIDE

PANEL BELOW DRUG FACTS

Indications and Usage (uses)

Temporarily relieves symptoms of earache in children, including: ■ minor fever ■ ear pain or throbbing ■ common pain or

itching of "swimmer’s ear" ■ irritability or occasional sleeplessness associated with earaches after diagnosis by a physician

Dosage and Administration (directions)

Shake well before using.

Children ages 2 years and over: Tilt head sideways and apply 3-4 drops into involved ear (Tip of applicator should not enter ear canal). Keep head tilted for at least 2 minutes to keep drops in ear. Repeat until relieved, up to 4 times daily.


Structured Label Content

Uses

Temporarily relieves symptoms of earache in children, including: ■ minor fever ■ ear pain or throbbing ■ common pain or

itching of "swimmer’s ear" ■ irritability or occasional sleeplessness associated with earaches after diagnosis by a physician

Section 42229-5 (42229-5)

"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Section 50565-1 (50565-1)

Keep this and all medications out of the reach of children. If swallowed, 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.

Section 50568-5 (50568-5)

Consult a physician if: ■ symptoms persist for more than 48 hours or worsen. ■ discharge from ear is present. ■ symptoms are accompanied by a high fever (over 101°F).

Section 50570-1 (50570-1)

Do not use if you have ear tubes, damaged ear drums or after ear surgery.

Section 53414-9 (53414-9)

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

Section 55106-9 (55106-9)

Active ingredients

Purpose

Belladonna 30C HPUS

(less than 0.000000000001% Alkaloids, calculated)

minor fever

Calcarea Carbonica 30C HPUS

throbbing ear pain

Chamomilla 30C HPUS

occasional sleeplessness and irritability

Lycopodium 30C HPUS

ear pain

Pulsatilla 30C HPUS

ear itching, pain worse at night

Sulphur 30C HPUS

ear pain with burning

Purpose

Relieves earache due to swimmer’s ear, cold, flu & allergy

Warnings

Keep away from eyes. Do not take by mouth.

Earache drops are only to be used in ears.

Directions

■ Shake well before using.

Children ages 2 years and over: Tilt head sideways and apply 3-4 drops into involved ear (Tip of applicator should not enter ear canal). Keep head tilted for at least 2 minutes to keep drops in ear. Repeat until relieved, up to 4 times daily.

Other Information (Other information)

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

■ Store at room temperature.

■ Do not refrigerate.

Inactive Ingredients (Inactive ingredients)

Citric Acid, Glycerine, Purified Water, Sodium Benzoate.

Questions Or Comments? (Questions or comments?)

(800) 624-9659

Principal Display Panel

HOMEOPATHIC

NDC 54973-3392-1

2-12

YEARS

NEW

LOOK

4 KIDS

SINCE 1903

Hyland's

Earache

Relief*

Relieves earache

due to swimmer’s ear,

cold, flu & allergy

NO DYES or PARABENS

NO NUMBING EFFECT

NATURAL

RELIEF*

0.33 FL. OZ. (10 mL)

*SEE NOTE ON SIDE

PANEL BELOW DRUG FACTS

Indications and Usage (uses) (Indications and Usage (Uses))

Temporarily relieves symptoms of earache in children, including: ■ minor fever ■ ear pain or throbbing ■ common pain or

itching of "swimmer’s ear" ■ irritability or occasional sleeplessness associated with earaches after diagnosis by a physician

Dosage and Administration (directions) (Dosage and Administration (Directions))

Shake well before using.

Children ages 2 years and over: Tilt head sideways and apply 3-4 drops into involved ear (Tip of applicator should not enter ear canal). Keep head tilted for at least 2 minutes to keep drops in ear. Repeat until relieved, up to 4 times daily.


Advanced Ingredient Data


Raw Label Data

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