COLD RELIEF ALCOHOL FREE CHERRY SYRUP- pelargonium sidoides syrup

Cold Relief Alcohol Free Cherry Syrup by

Drug Labeling and Warnings

Cold Relief Alcohol Free Cherry Syrup by is a Homeopathic medication manufactured, distributed, or labeled by Schwabe North America, Inc, ProSolutions, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

PELARGONIUM SIDOIDES 1X

Inactive Ingredients

ARONIA JUICE

CITRIC ACID

ETHYL ALCOHOL 

FRUCTOSE

GLYCERIN

MALTODEXTRIN

NATURAL FLAVOR

POTASSIUM SORBATE

PURIFIED WATER

Dosage & Administration:

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.

Use only with enclosed dosage cup.

Adults and children 13 years of age and older: Take 1 1/2 teaspoon (tsp) (7.5mL) three times daily.
Children 6-12 years of age: Take 1 teaspoon (5mL) three times daily.
Children under 1-5 years of age: Take 1/2 teaspoon (2.5 mL) three times daily.

Indications and Usage Section

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

Purpose

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

Warnings

Sore throat warning: If sore throat is severe, persistes 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.

Individuals with allergies to plants of the Geraniaceae family should use this product with caution. 

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 ALCOHOL FREE CHERRY SYRUP 
pelargonium sidoides syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-4463
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 120 mL

Inactive Ingredients
Ingredient Name	Strength
ARONIA MELANOCARPA FRUIT JUICE (UNII: D2EVP827PJ)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ALCOHOL (UNII: 3K9958V90M)
FRUCTOSE (UNII: 6YSS42VSEV)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
WATER (UNII: 059QF0KO0R)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (NATURAL CHERRY FLAVOR)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-4463-4	3 in 1 CARTON	05/22/2023
1		120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/22/2023

Labeler - Schwabe North America, Inc (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe North America, Inc		831153908	manufacture(53499-4463)

Establishment
Name	Address	ID/FEI	Business Operations
ProSolutions, Inc.		070769782	label(53499-4463) , pack(53499-4463)