Cold Relief Drops

Cold Relief Drops
SPL v2
SPL
SPL Set ID 6179a822-3485-457f-846a-e6148df26543
Route
ORAL
Published
Effective Date 2025-10-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pelargonium Sidoides Root (1 [hp_X])
Inactive Ingredients
Alcohol Maltodextrin Glycerin Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-08-14

Description

Pelargonium sidoides 1X

Purpose

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat.


Medication Information

Purpose

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat.

Description

Pelargonium sidoides 1X

Section 51945-4

Stop Use

Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache.

These could be signs of a serious condition.

Warnings

Sore throat warning: if sore throat is severe, persists more than 2 days, is accompanied or followed by a fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Ask Doctor

Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, a cough that is accompanied by excessive phlegm (mucus), been taking any medications, an allergy to plants of the Geraniaceae family.

Overdosage

In case of overdose, seek medical help or contact a Poison Control Center right away.

Active Ingredient

Pelargonium sidoides 1X

Inactive Ingredient

Ethyl Alcohol

Glycerin

Maltodextrin

Purified Water

Indications & Usage

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat.

Dosage & Administation

Directions:

For best results, use at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease. 

Shake well before each use.

Adults & children 13 years of age and older: take 1.5 mL three times daily by mouth.

Children 12 years of age and under: consult a physician before use.

Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep Out of Reach of Children

Keep out of reach of children.


Structured Label Content

Section 51945-4 (51945-4)

Purpose

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat.

Stop Use

Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache.

These could be signs of a serious condition.

Warnings

Sore throat warning: if sore throat is severe, persists more than 2 days, is accompanied or followed by a fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Ask Doctor

Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, a cough that is accompanied by excessive phlegm (mucus), been taking any medications, an allergy to plants of the Geraniaceae family.

Overdosage

In case of overdose, seek medical help or contact a Poison Control Center right away.

Active Ingredient

Pelargonium sidoides 1X

Inactive Ingredient

Ethyl Alcohol

Glycerin

Maltodextrin

Purified Water

Indications & Usage

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat.

Dosage & Administation

Directions:

For best results, use at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease. 

Shake well before each use.

Adults & children 13 years of age and older: take 1.5 mL three times daily by mouth.

Children 12 years of age and under: consult a physician before use.

Pregnancy Or Breast Feeding (Pregnancy or Breast-Feeding)

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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