COLD RELIEF SYRUP CHERRY- 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 Cherry Syrup

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

LHBN15793_C02_ColdRelief_Cherry_8oz_CTN_FNL.jpg

Add image transcription here...

COLD RELIEF SYRUP CHERRY 
pelargonium sidoides syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-6273
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 240 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorCHERRY (NATURAL CHERRY FLAVOR) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-6273-51 in 1 CARTON08/25/2023
1120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:53499-6273-91 in 1 CARTON08/25/2023
2240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/25/2023
Labeler - Schwabe North America, Inc (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe North America, Inc831153908manufacture(53499-6273)

Revised: 10/2023
Document Id: 0c4fd62c-54d6-4480-aaa9-4e4d80452ab8
Set id: cf5e01bb-ff17-4a72-b02d-4c3296795947
Version: 2
Effective Time: 20231013
 
Schwabe North America, Inc