COLD RELIEF ZERO SUGAR GRAPE- pelargonium sidoides 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.

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Cold Relief Zero Sugar Grape Syrup

Active Ingredient

Pelargonium sidoides 1X

Inactive Ingredients

Citric Acid

Ethyl Alcohol

Glycerin

Maltodextrin

Natural Flavor

Potassium Sorbate

Purified Water

Red Cabbage Juice Color

Sorbitol

Dosage and 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.

Use only with enclosed dosage cup.

Adults & children 13 years of age and older: Take 1 ½ teaspoon (tsp) (7.5 mL) three times daily.

Children 6-12 years of age: Take 1 teaspoon (5mL) three times daily.

Children under 6 years of age: Consult a doctor.

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 the 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.

Stope 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, or 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, seeek medical help or contact a Poison Control Center immediatley.

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COLD RELIEF ZERO SUGAR GRAPE 
pelargonium sidoides syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-6794
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E) PELARGONIUM SIDOIDES ROOT1 [hp_X]  in 120 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ALCOHOL (UNII: 3K9958V90M)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
WATER (UNII: 059QF0KO0R)  
CABBAGE (UNII: GW0W1Y9I97)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (NATURAL GRAPE FLAVOR) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-6794-51 in 1 CARTON03/06/2024
1120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/06/2024
Labeler - Schwabe North America, Inc (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe North America831153908manufacture(53499-6794)

Revised: 3/2024
Document Id: 87f89b80-cc75-401f-a32c-4d70956c01fc
Set id: 9160182c-a1c1-49db-8a3d-01a30f7cbd78
Version: 1
Effective Time: 20240306
 
Schwabe North America, Inc