Chestal Childrens Cough And Cold

Chestal Childrens Cough And Cold
SPL v9
SPL
SPL Set ID cc5d12f6-9d39-48ff-b295-59bd592c84df
Route
ORAL
Published
Effective Date 2024-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Solanum Dulcamara Top (5 [hp_C]) Ferrosoferric Phosphate (9 [hp_C]) Goldenseal Dichromate Ion Strychnos Nux-vomica Seed
Inactive Ingredients
Citric Acid Monohydrate Water Sodium Benzoate Sucrose Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2013-06-01

Description

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.


Medication Information

Warnings and Precautions

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

Indications and Usage

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
Dosage and Administration

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.

Description

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.

Section 42229-5

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.

Section 50565-1

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

Section 50566-9

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.

Section 50569-3

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).

Section 51727-6

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

Section 51945-4

Section 53413-1

BoironUSA.com

[email protected]

1-800-BOIRON-1

(1-800-264-7661),

Made in France

Distributed by Boiron, Inc. Newtown Square, PA 19073

Section 55105-1

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

Section 55106-9

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.


Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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

Section 42229-5 (42229-5)

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.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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.

Section 50569-3 (50569-3)

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).

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

BoironUSA.com

[email protected]

1-800-BOIRON-1

(1-800-264-7661),

Made in France

Distributed by Boiron, Inc. Newtown Square, PA 19073

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

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.


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