KIDS RELIEF EAR RELIEF

Manufacturer
HOMEOLAB USA INC
Effective date
2014-01-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:37:39

Label at a glance#

ProductKIDS RELIEF EAR RELIEF
Active ingredientFERRUM PHOSPHORICUM, CAPSICUM ANNUUM WHOLE, RANCID BEEF, ARSENIC TRIOXIDE, ATROPA BELLADONNA
Label structure9 sections

Indications and uses

This oral homeopathic medicine is made from a combination of ingredients traditionnally used to help relieve the sensation of fullness of the ear, sensitivity to water and drafts, and the annoyance of water-logged ears by helping clear water trapped in the ear. *These statements have not been reviewed by the Food and Drug Administration. This product is manufactured using traditional homeopathic principles of dilu...

Dosage and administration

Do not use more than directed. Do not take with food. Take 0.75 mL orally. Repeat every 8 hours and reduce with improvement or as directed by a healthcare professional. Infants and children 0 to 9 years of age: 0.75 mL

Storage and handling

Store at room temperature.

Label contents#

Full prescribing information#

Active ingredients HPUS*

OTC - ACTIVE INGREDIENT SECTION

Ferrum phosphoricum (Ferrosoferric phosphate) 30X

Capsicum annuum (Cayenne pepper) 30X

Pyrogenium (Pyrogen) 30X

Arsenicum album (Arsenous oxide) 30X

Belladonna (Deadly nightshade) 30X

Purpose

OTC - PURPOSE SECTION

Ferrum phosphoricum (Ferrosoferric phosphate) 30X............................................sensitivity to touch

Capsicum annuum (Cayenne pepper) 30X...........................................................sensitivity to touch

Pyrogenium (Pyrogen) 30X................................................................................coldness and chilliness

Arsenicum album (Arsenous oxide) 30X...............................................................burning sensation of the ear

Belladonna (Deadly nightshade) 30X...................................................................fullness of the ear, night time calmative

REFERENCES SECTION

The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.

Uses

INDICATIONS & USAGE SECTION

This oral homeopathic medicine is made from a combination of ingredients traditionnally used to help relieve the sensation of fullness of the ear, sensitivity to water and drafts, and the annoyance of water-logged ears by helping clear water trapped in the ear.

*These statements have not been reviewed by the Food and Drug Administration. This product is manufactured using traditional homeopathic principles of dilution.

RETAIN CARTON FOR COMPLETE INSTRUCTIONS

Warnings

WARNINGS SECTION


Do not use if imprinted shrink seal neckband is broken or missing.

OTC - STOP USE SECTION

Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist for more than 2 days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 

Directions

DOSAGE & ADMINISTRATION SECTION

Do not use more than directed.

Do not take with food.

Take 0.75 mL orally.

Repeat every 8 hours and reduce with improvement or as directed by a healthcare professional.

Infants and children 0 to 9 years of age: 0.75 mL

Other information

STORAGE AND HANDLING SECTION

Store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water, sorbitol, grape and raspberry flavor, sodium benzoate, potassium sorbate, citric acid.

CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of cartonimage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60512-9163-82025-12-28C16284748780-19d75b9d0-fa5a-f424-e053-dadaa90a57ceDRUGS FACTS
60512-9163-82020-01-31C16284748780-19d75b9d0-fa5a-f424-e053-dadaa90a57ceDRUGS FACTS

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60512-9163KIDS RELIEF EAR RELIEF (FERRUM PHOSPHORICUM, CAPSICUM ANNUUM, PYROGENIUM, ARSENICUM ALBUM, BELLADONNA) LIQUID [HOMEOLAB USA INC]1Legacy NDC20140117_70ef084a-b2e8-4afa-90e3-c921a78afd3f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HO1
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H1
CAPSICUM ANNUUM WHOLEACTIVE INGREDIENT7FKZ3QQQ1F1
FERRUM PHOSPHORICUMACTIVE INGREDIENT91GQH8I5F71
RANCID BEEFACTIVE INGREDIENT29SUH5R3HU1
ARSENIC CATION (3+)ACTIVE MOIETYC96613F5AV1
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H1
CAPSICUM ANNUUM WHOLEACTIVE MOIETY7FKZ3QQQ1F1
FERROSOFERRIC PHOSPHATEACTIVE MOIETY91GQH8I5F71
RANCID BEEFACTIVE MOIETY29SUH5R3HU1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ41
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SORBITOLINACTIVE INGREDIENT506T60A25R1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60512-916360512-9163-8

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 186 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii candidate
88 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRASYNOVIAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, COATED / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSPRAY / NASAL49 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RAEROSOL, FOAM / TOPICAL4.95 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / ORAL114 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAMUSCULAR0.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOAP / TOPICAL0.5 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, EXTENDED RELEASE / ORAL428 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYSTEM / TOPICAL2 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSPRAY / NASAL9 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION, SOLUTION / INTRAMUSCULAR4.8 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / INTRAVENOUS0.2 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SOLUTION / ORAL315 mgExact identifier — unii candidate
88 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUELIXIR / ORAL5.02 mg/5mlExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii candidate
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPFILM / SUBLINGUAL10 mgExact identifier — unii candidate
88 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPOWDER / ORAL36000 mgExact identifier — unii candidate
44 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4AEROSOL, FOAM / TOPICAL8 mgExact identifier — unii candidate
19 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCONCENTRATE / ORAL5.3 mg/1mlExact identifier — unii candidate
88 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SYRUP / ORAL2 mg/1mlExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO / TOPICAL17 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINHALANT / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / AURICULAR (OTIC)0.04 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCREAM / VAGINAL0.49 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET / ORAL914 mgExact identifier — unii candidate
88 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CREAM / TOPICAL0.25 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGEL / TOPICAL1 mgExact identifier — unii candidate
88 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RLOTION / TOPICAL10.7 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSWAB / TOPICAL0.05 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / SUBCUTANEOUS26 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION, CONCENTRATE / INTRAVENOUSNAExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAVENOUS2068 mgExact identifier — unii candidate
88 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4EMULSION / OPHTHALMIC0.47 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRATHECALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET / ORAL337.28 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / OPHTHALMIC6 mgExact identifier — unii candidate
44 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR38 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / SUBCUTANEOUS28 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPOWDER, FOR SUSPENSION / ORAL160 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION, EMULSION / INTRAVENOUS0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / ORAL28 mgExact identifier — unii candidate
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCREAM / TOPICAL4 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / PERIDURALNAExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION/ DROPS / ORAL19 mgExact identifier — unii candidate
88 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii candidate
44 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRABURSALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRA-ARTICULAR45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAPLEURALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / NASAL2.8 mg/1mlExact identifier — unii candidate
88 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
470ee698-e9e9-1826-e063-6394a90a088b70ef084a-b2e8-4afa-90e3-c921a78afd3f2025-12-28WarningsExact identifier
spl set id: 70ef084a-b2e8-4afa-90e3-c921a78afd3f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.