COLD RELIEF DROPS- pelargonium sidoides liquid

Cold Relief Drops by

Drug Labeling and Warnings

Cold Relief Drops by is a Homeopathic medication manufactured, distributed, or labeled by Schwabe North America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Pelargonium sidoides 1x

Inactive Ingredient

Citric Acid

Ethyl Alcohol

Glycerin

Maltodextrin

Potassium Sorbate

Purified Water

Sorbitol

Dosage & Administration

Directions:

For best results, use at 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 6-12 years of age: Take 1 mL three times daily by mouth.

Children 1-5 years of age: Take 0.5 mL three times daily by mouth.

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.

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.

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.

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.

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.

Overdose

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

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

COLD RELIEF DROPS 
pelargonium sidoides liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-8271
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E)	PELARGONIUM SIDOIDES ROOT	1 [hp_X]  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-8271-8	1 in 1 CARTON	08/26/2024
1		59 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 53499-8271-4	1 in 1 CARTON	08/26/2024
2		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/26/2024

Labeler - Schwabe North America, Inc. (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe North America, Inc.		831153908	manufacture(53499-8271)