COLD RELIEF KIDS CHERRY- pelargonium sidoides tablet, chewable 
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 Kids Cherry 10 chew tabs 

Active Ingredient

PELARGONIUM SIDOIDES 1X

Inactive Ingredients

CITRIC ACID

MAGNESIUM STEARATE

MALIC ACID

MALTODEXTRIN

MANNITOL

NATURAL FLAVOR

SODIUM CROSCARMELLOSE

SORBITOL

STEARIC ACID

XYLITOL

Dosage and Administration

Directions

Chew or dissolve tablets in the mouth. Do not swallow whole.

For best results, use at first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.

Adults & children 13 years of age and older: Take 1 chewable tablet 3 times daily.
Children 6-12 years of age: Take 1 chewable tablet 2 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 a 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 you are pregnant or breast-feeding, ask a healthcare professional before use.

Keep out of reach of children

Keep out reach of children.

Overdose

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

LHBN12351_02_ColdRelief_Kids_Cherry-_10ct_FNL.jpg

Add image transcription here...

COLD RELIEF KIDS CHERRY 
pelargonium sidoides tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-3351
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]
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALIC ACID (UNII: 817L1N4CKP)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MANNITOL (UNII: 3OWL53L36A)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SORBITOL (UNII: 506T60A25R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Colorpink (CHERRY TABLET) Scoreno score
ShapeROUND (C) Size16mm
FlavorCHERRY (NATURAL CHERRY FLAVOR) Imprint Code C
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-3351-01 in 1 CARTON07/11/2023
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/11/2023
Labeler - Schwabe North America, Inc (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe North America, Inc.831153908manufacture(53499-3351)

Revised: 10/2023
Document Id: 71e3891f-25d5-47af-9c87-4144eeff1f8f
Set id: fa739686-c938-4173-a001-cb39fc4db442
Version: 2
Effective Time: 20231013
 
Schwabe North America, Inc