Cold Relief Alcohol Free Cherry Syrup: Homeopathic Product Information

COLD RELIEF ALCOHOL FREE CHERRY SYRUP- pelargonium sidoides root syrup
Schwabe North America, Inc

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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.

Add image transcription here…

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PELARGONIUM SIDOIDES ROOT (PELARGONIUM SIDOIDES ROOT) PELARGONIUM SIDOIDES ROOT 1 [hp_X] in 120 mL

Inactive Ingredients Ingredient Name Strength ARONIA MELANOCARPA FRUIT JUICE ANHYDROUS CITRIC ACID ALCOHOL FRUCTOSE MALTODEXTRIN WATER POTASSIUM SORBATE GLYCERIN

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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:53499-4463-4 3 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC 1 120 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (53499-4463-4)

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	Operations
Schwabe North America, Inc		831153908	manufacture (53499-4463)

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

Revised: 05/2023 Schwabe North America, Inc