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SPL v5

SPL

SPL Set ID fbce712e-3073-4afd-adfe-19fb55c6689b

Route

ORAL

Published

Effective Date 2018-07-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Drosera Rotundifolia Flowering Top (1 [hp_C]) Arnica Montana (3 [hp_C]) Bryonia Alba Whole Ipecac Cetraria Islandica Subsp. Islandica Cochineal Corallium Rubrum Whole Tin

Inactive Ingredients

Sorbitol Water Caramel Sodium Benzoate Potassium Sorbate Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2018-03-03

Description

Active Ingredients HPUS: Drosera 1C Arnica Montana 3C Bryonia 3C Ipecacuanha 3C Cetraria islandica 1C Coccus cacti 3C Corallium rubrum 3C Stannum metallicum 3C

Medication Information

Warnings and Precautions

Warnings

Stop use and ask a doctor if •pain or cough gets worse or lasts

more than 5 days ( children) or 7 days (adults) •fever gets worse

or lasts more than 3 days •redness or swelling is present •new

symptoms occur •cough comes back or occurs with rash or

headache that lasts. These could be signs of a serious condition.

Indications and Usage

Uses This homeopathic medicine is made from a

combination of ingredients traditionally used to help

relieve symptoms associated with cough and cold*:

•dry cough •cough with expectoration

•chest congestion •fever •aches and pains

Dosage and Administration

Directions • Children under 6 months of age: Consult

a licensed healthcare practitioner before using this product

• Children 6 months to 2 years old: 2.5ml or 1/2 teaspoon

every 6 hours or 4 times a day • Children 2 to 12 years

old: 5ml or 1 teaspoon, every 6 hours or 4 times a day.

Description

Active Ingredients HPUS: Drosera 1C Arnica Montana 3C Bryonia 3C Ipecacuanha 3C Cetraria islandica 1C Coccus cacti 3C Corallium rubrum 3C Stannum metallicum 3C

Section 44425-7

Other information •Store at room temperature.

•Do not use if seal is broken or missing.

Section 51727-6

Inactive ingredients Purified water, sorbitol,

caramel, sodium benzoate, potassium sorbate, citric acid

Section 51945-4

Section 55105-1

Purpose

Drosera 1C............................dry cough

Arnica Montana 3C..................aches and pains, chest congestion

Bryonia 3C.............................painful cough

Ipecacuanha 3C......................night cough

Cetraria islandica 1C...............cough with expectoration

Coccus cacti 3C......................cough with expectoration

Corallium rubrum 3C...............painful cough

Stannum metallicum 3C...........coughs, chills and lessens mucus

The letters "HPUS" indicate that the components in this product are officially

monographed in the Homeopathic Pharmacopoeia of the United States.

Section 55106-9

Active Ingredients HPUS:

Drosera 1C

Arnica Montana 3C

Bryonia 3C

Ipecacuanha 3C

Cetraria islandica 1C

Coccus cacti 3C

Corallium rubrum 3C

Stannum metallicum 3C

Structured Label Content

Indications and Usage (34067-9)

Uses This homeopathic medicine is made from a

combination of ingredients traditionally used to help

relieve symptoms associated with cough and cold*:

•dry cough •cough with expectoration

•chest congestion •fever •aches and pains

Dosage and Administration (34068-7)

Directions • Children under 6 months of age: Consult

a licensed healthcare practitioner before using this product

• Children 6 months to 2 years old: 2.5ml or 1/2 teaspoon

every 6 hours or 4 times a day • Children 2 to 12 years

old: 5ml or 1 teaspoon, every 6 hours or 4 times a day.

Warnings and Precautions (34071-1)

Warnings

Stop use and ask a doctor if •pain or cough gets worse or lasts

more than 5 days ( children) or 7 days (adults) •fever gets worse

or lasts more than 3 days •redness or swelling is present •new

symptoms occur •cough comes back or occurs with rash or

headache that lasts. These could be signs of a serious condition.

Section 44425-7 (44425-7)

Other information •Store at room temperature.

•Do not use if seal is broken or missing.

Section 51727-6 (51727-6)

Inactive ingredients Purified water, sorbitol,

caramel, sodium benzoate, potassium sorbate, citric acid

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Drosera 1C............................dry cough

Arnica Montana 3C..................aches and pains, chest congestion

Bryonia 3C.............................painful cough

Ipecacuanha 3C......................night cough

Cetraria islandica 1C...............cough with expectoration

Coccus cacti 3C......................cough with expectoration

Corallium rubrum 3C...............painful cough

Stannum metallicum 3C...........coughs, chills and lessens mucus

The letters "HPUS" indicate that the components in this product are officially

monographed in the Homeopathic Pharmacopoeia of the United States.

Section 55106-9 (55106-9)

Active Ingredients HPUS:

Drosera 1C

Arnica Montana 3C

Bryonia 3C

Ipecacuanha 3C

Cetraria islandica 1C

Coccus cacti 3C

Corallium rubrum 3C

Stannum metallicum 3C

Advanced Ingredient Data

[{"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARAMEL", "unii": "T9D99G2B1R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DROSERA ROTUNDIFOLIA FLOWERING TOP", "unii": "75O014T1HG", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "ARNICA MONTANA", "unii": "O80TY208ZW", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "BRYONIA ALBA WHOLE", "unii": "56K0VVT47P", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "IPECAC", "unii": "62I3C8233L", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "CETRARIA ISLANDICA SUBSP. ISLANDICA", "unii": "BJ7YPN79A1", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "COCHINEAL", "unii": "TZ8Z31B35M", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "CORALLIUM RUBRUM WHOLE", "unii": "22Z32PWR7R", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "TIN", "unii": "387GMG9FH5", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated with cough and cold*: •dry cough •cough with expectoration •chest congestion •fever •aches and pains", "34068-7": "Directions • Children under 6 months of ag e: Consult a licensed healthcare practitioner before using this product • Children 6 months to 2 years ol d: 2.5ml or 1/2 teaspoon every 6 hours or 4 times a day • Children 2 to 12 years old : 5ml or 1 teaspoon, every 6 hours or 4 times a day. ", "34071-1": "Warnings Stop use and ask a doctor if •pain or cough gets worse or lasts more than 5 days ( children) or 7 days (adults) •fever gets worse or lasts more than 3 days •redness or swelling is present •new symptoms occur •cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. ", "44425-7": "Other information •Store at room temperature. •Do not use if seal is broken or missing. ", "51727-6": "Inactive ingredients Purified water, sorbitol, caramel, sodium benzoate, potassium sorbate, citric acid ", "55105-1": "Purpose Drosera 1C............................dry cough Arnica Montana 3C..................aches and pains, chest congestion Bryonia 3C.............................painful cough Ipecacuanha 3C......................night cough Cetraria islandica 1C...............cough with expectoration Coccus cacti 3C......................cough with expectoration Corallium rubrum 3C...............painful cough Stannum metallicum 3C...........coughs, chills and lessens mucus The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. ", "55106-9": "Active Ingredients HPUS: Drosera 1C Arnica Montana 3C Bryonia 3C Ipecacuanha 3C Cetraria islandica 1C Coccus cacti 3C Corallium rubrum 3C Stannum metallicum 3C"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:11:37.759792 · Updated: 2026-03-14T23:17:39.188617