FDA.reportPublic FDA data

Chestal Childrens Cough and Cold

Manufacturer
Laboratoires Boiron | Boiron Inc. | Boiron
Effective date
2024-03-06
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 02:26:17

Label at a glance#

ProductChestal Childrens Cough and Cold
Active ingredientSOLANUM DULCAMARA TOP, FERRUM PHOSPHORICUM, GOLDENSEAL, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients** (in each mL)

Dulcamara 5C HPUS (0.13 mg)

Ferrum phosphoricum 9C HPUS (0.13 mg)

Hydrastis canadensis 9C HPUS (0.13 mg) (contains less than 10 -19 mg hydrastine and berberine alkaloids)

Kali Bichromicum 9C HPUS (0.13 mg) (contains less than 10 -19 mg chromium)

Nux Vomica 9C HPUS (0.13 mg) (contains less than 10 -20 strychnine alkaloids)

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Purpose*

Dulcamara 5C HPUS ... Relieves cold and coughs worsened by exposure to damp cold

Ferrum phosphoricum 9C HPUS ... Relieves colds with gradual onset, minor sore throat, and dry, fitful cough

Hydrastis canadensis 9C HPUS ... Relieves colds and coughs associated with runny nose

Kali Bichromicum 9C HPUS ... Relieves nasal discharge

Nux Vomica 9C HPUS (0.13mg) ... Relieves sneezing fits

INDICATIONS & USAGE SECTION

Uses*

temporarily relieves symptoms of the common cold such as:

  • nasal and chest congestion
  • fitful cough
  • sneezing
  • occasional minor sore throat
  • runny or stuff nose

WARNINGS SECTION

Do not use if your child is allergic to any of this product's ingredients.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if your child has

  • severe sore throat that is accompanied or followed by fever, headache, rash, nausea, or vomiting
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus).

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • sore throat worsens or persists for more than 2 days
  • cough or nasal congestion worsens or lasts for more then 5 days in children under 12 years of age, comes back, or is accompanied by fever, rash, or a persistent headache
  • new symptoms occur. These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

Children 6 to under 12 years of age At the onset of symptoms, take 5 mL ǂ as needed, up to 6 times per day

Children 4 to under 6 years of age At the onset of symptoms, take 5 mLǂ as needed, up to 3 times per day

Children under 4 years of age Not recommended

ǂ Use only with dosing cup provided.

Do not use dosing cup with other products.

SPL UNCLASSIFIED SECTION

Other information

do not use if glued carton end flaps are open or if the seal at base of cap is broken or missing

retain this carton for full drug facts
contains 4.3 g of sugar per 5 mL
dispose of 1 year after opening

contains 0.000005% alcohol

40 Doses

6.7 fl oz. (200 mL)

Multi-Symtom Cold & Cough*

Cold & Cough Relief*

Nasal & Chest Congestion Cough Runny Nose*

Non-Drowsy

No known drug interactions

No artifical sweetners, flavors or dyes

Day & Night Relief

Kid-Friendly Taste

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
**C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

INACTIVE INGREDIENT SECTION

alcohol, citric acid, purified water, sodium benzoate, sucrose

OTC - QUESTIONS SECTION

BoironUSA.com

Info@boiron.com

1-800-BOIRON-1
(1-800-264-7661),

Made in France

Distributed by Boiron, Inc. Newtown Square, PA 19073

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabellabellabellabellabellabelboxbox

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9068-28Chestal Childrens Cough and Cold1 in 1 PACKAGESYRUP19
0220-9068-28Chestal Childrens Cough and Cold200 mL in 1 BOTTLESYRUP2009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9068CHESTAL CHILDRENS COUGH AND COLD (SOLANUM DULCAMARA TOP, FERRUM PHOSPHORICUM, GOLDENSEAL, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEED) SYRUP [LABORATOIRES BOIRON]9Current NDC, Legacy NDC, 2 package rows20240308_cc5d12f6-9d39-48ff-b295-59bd592c84df.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
FERRUM PHOSPHORICUMACTIVE INGREDIENT91GQH8I5F74
GOLDENSEALACTIVE INGREDIENTZW3Z11D0JV4
POTASSIUM DICHROMATEACTIVE INGREDIENTT4423S18FM4
SOLANUM DULCAMARA TOPACTIVE INGREDIENTKPS1B1162N4
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139194
DICHROMATE IONACTIVE MOIETY9LKY4BFN2V4
FERROSOFERRIC PHOSPHATEACTIVE MOIETY91GQH8I5F74
GOLDENSEALACTIVE MOIETYZW3Z11D0JV4
SOLANUM DULCAMARA TOPACTIVE MOIETYKPS1B1162N4
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139194
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU4
SUCROSEINACTIVE INGREDIENTC151H8M5544
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-90680220-9068-28

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCROSEC151H8M554IACT
SOLANUM DULCAMARA TOPKPS1B1162NACTIB
FERRUM PHOSPHORICUM91GQH8I5F7ACTIB
GOLDENSEALZW3Z11D0JVACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
ALCOHOL3K9958V90MIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chestal Childrens Cough and ColdSOLANUM DULCAMARA TOP, FERRUM PHOSPHORICUM, GOLDENSEAL, POTASSIUM DICHROMATE, STRYCHNOS NUX-VOMICA SEEDLaboratoires Boironcc5d12f6-9d39-48ff-b295-59bd592c84df2024-03-06WarningsExact identifier
ndc (package): 0220-9068-28
ndc (product): 0220-9068
ndc11 (package): 00220906828
spl id: 1302c511-eb20-5818-e063-6394a90a9225
spl set id: cc5d12f6-9d39-48ff-b295-59bd592c84df

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.