Boiron Stodaline Sugar-Free Cough Syrup – 200 ml

Boiron Stodaline Sugar-Free Cough Syrup – 200 ml

Traditionally used for Cough Relief – From Age 2 and Up

Description:
Boiron Stodaline Sugar-Free Syrup is a homeopathic medicine traditionally used for the treatment of coughs. Suitable for children aged 2 and older, adolescents, and adults, this syrup provides gentle yet effective relief from cough symptoms.

Who It's For:

• Baby (from age 2), Child, Teenager, Adult
  Pregnancy & Breastfeeding: Not recommended

Form: Oral syrup
Flavor: Blackberry-Vanilla

Homeopathic Active Ingredients (per 100 g):

• Antimonium tartaricum 6 CH – 2 g

• Bryonia 3 CH – 2 g

• Coccus cacti 4 CH – 2 g

• Drosera 3 CH – 2 g

• Ipeca 3 CH – 2 g

• Rumex crispus 6 CH – 2 g

• Spongia tosta 4 CH – 2 g

• Sticta pulmonaria 3 CH – 2 g

Excipients: Liquid maltitol, sorbitol (E420), sodium benzoate (E211), citric acid monohydrate (E330), blackberry flavor*, vanilla flavor*, purified water.
*Flavors contain propylene glycol (E1520).

Excipients with known effects: Maltitol, sorbitol, sodium benzoate, propylene glycol

Dosage and Administration: (Oral use with included measuring cup)

• Children 24 to 35 months (12–15 kg): 2.5 ml once per day

• Children 3 to 11 years (15–40 kg): 2.5 ml twice per day

• Adolescents (12 to 18 years): 5 ml 2 to 3 times per day

• Adults: 15 ml 3 to 5 times per day

Treatment Duration:

• Space doses based on symptom improvement.

• Discontinue when cough subsides.

• Consult your doctor if no improvement after 3 days.

• Maximum duration: 1 week

Precautions for Use:

• Do not use if allergic to any active substances or excipients.

• In case of sugar intolerance, consult a doctor before use.

• Not suitable for patients with fructose intolerance.

• May cause mild digestive upset (e.g., diarrhea) due to maltitol and sorbitol.

Content per Dose (2.5 ml / 5 ml / 15 ml):

• Sorbitol: 0.6 g / 1.2 g / 3.7 g

• Sodium Benzoate (as benzoic acid): 5.2 mg / 10.4 mg / 31.3 mg

• Sodium: 1 mg / 2 mg / 6 mg → Essentially sodium-free (<1 mmol per dose)

• Propylene Glycol: 3.7 mg / 7.5 mg / 22.5 mg

Storage: Use within 1 year after opening.

Packaging: 200 ml bottle

Tip: If your cough is accompanied by cold symptoms, consider pairing with Boiron Storinyl Syrup for additional relief.

Before use or consult your doctor or pharmacist.

Please read the following full disclosure before purchasing or using this product. 

SUMMARY OF PRODUCT CHARACTERISTICS

ANSM – Updated on: 04/21/2021

1. NAME OF THE MEDICINAL PRODUCT

STODALINE SUGAR-FREE, syrup sweetened with sorbitol and liquid maltitol

2. QUALITATIVE AND QUANTITATIVE COMPOSITION (per 100 g of syrup)

• Antimonium tartaricum 6CH – 2 g
• Bryonia 3CH – 2 g
• Coccus cacti 4CH – 2 g
• Drosera 3CH – 2 g
• Ipeca 3CH – 2 g
• Rumex crispus 6CH – 2 g
• Spongia tosta 4CH – 2 g
• Sticta pulmonaria 3CH – 2 g

Excipients with known effect: liquid maltitol, sorbitol (E420), sodium benzoate (E211), propylene glycol (E1520).
For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Syrup sweetened with sorbitol and liquid maltitol.

4. CLINICAL PARTICULARS

4.1 Therapeutic Indications

Homeopathic medicine traditionally used for the treatment of cough.

4.2 Posology and Method of Administration

For adults and children over two years old only.

Dosage:

• Children aged 24–35 months (approx. 12–15 kg): 1 dose of 2.5 ml using the measuring cup once per day
• Children aged 3–11 years (approx. 15–40 kg): 1 dose of 2.5 ml using the measuring cup twice per day
• Adolescents aged 12–18 years: 1 dose of 5 ml using the measuring cup 2 to 3 times per day
• Adults: 1 dose of 15 ml using the measuring cup 3 to 5 times per day

Treatment Duration: Space out doses as symptoms improve and stop treatment when symptoms disappear.
Treatment should not exceed one week.
If symptoms do not improve within 3 days, medical consultation is recommended.

Method of Administration: Oral use.

4.3 Contraindications

• Hypersensitivity to the active substances or any of the excipients listed in section 6.1.

4.4 Special Warnings and Precautions for Use

• This medicine contains 0.6 g, 1.2 g, or 3.7 g of sorbitol per dose of 2.5 ml, 5 ml, or 15 ml respectively (equivalent to 246 mg/ml). Sorbitol is a source of fructose.
  If you (or your child) have been informed by your doctor that you have an intolerance to certain sugars or have been diagnosed with hereditary fructose intolerance (HFI)—a rare genetic disorder—you must consult your doctor before using this medicine.

• Sorbitol and liquid maltitol may cause mild laxative effects and/or gastrointestinal discomfort.

• Caloric value: 2.3 kcal/g of liquid maltitol and 2.6 kcal/g of sorbitol.

• Contains sodium benzoate, equivalent to:

  • 5.2 mg of benzoic acid and 1 mg of sodium per 2.5 ml dose
  • 10.4 mg of benzoic acid and 2 mg of sodium per 5 ml dose
  • 31.3 mg of benzoic acid and 6 mg of sodium per 15 ml dose
    This medicine contains less than 1 mmol (23 mg) of sodium per dose and is therefore considered “sodium-free.”

• Contains propylene glycol:

  • 3.7 mg per 2.5 ml dose
  • 7.5 mg per 5 ml dose
  • 22.5 mg per 15 ml dose (equivalent to 1.5 mg/ml)

4.5 Interactions with Other Medicinal Products and Other Forms of Interaction

Not applicable.

4.6 Fertility, Pregnancy, and Lactation

In the absence of experimental and clinical data, use of this medicine is not recommended during pregnancy and breastfeeding as a precautionary measure.

4.7 Effects on Ability to Drive and Use Machines

Not applicable.

4.8 Undesirable Effects

Reporting of suspected adverse reactions:
Reporting suspected side effects after the medicine has been authorized is important for continued monitoring of the benefit/risk balance.
Healthcare professionals should report any suspected adverse effects via the national reporting system:
French National Agency for Medicines and Health Products Safety (ANSM) and network of Regional Pharmacovigilance Centers – Website: www.signalement-sante.gouv.fr

4.9 Overdose

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic Properties

Pharmacotherapeutic class: Homeopathic medicine.
In the absence of scientific data, the indication is based on the traditional homeopathic use of the components.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Not applicable.

6. PHARMACEUTICAL PARTICULARS

6.1 List of Excipients

Liquid maltitol, sorbitol (E420), sodium benzoate (E211), citric acid monohydrate (E330), blackberry flavor*, vanilla flavor*, purified water.
*Flavors contain propylene glycol (E1520).

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

• 4 years before opening
• 1 year after first opening

6.4 Special Precautions for Storage

No special storage precautions required.

6.5 Nature and Contents of Container

• 200 ml syrup bottle (type III glass) with or without drip-free pourer.
• Box of 1 bottle (200 ml) + 1 measuring cup (polypropylene, 15 ml capacity, graduated at 2.5 ml, 5 ml, and 15 ml).

6.6 Special Precautions for Disposal and Handling

Not applicable.

7. MARKETING AUTHORIZATION HOLDER

BOIRON
2 Avenue de l’Ouest Lyonnais
69510 Messimy
France

8. MARKETING AUTHORIZATION NUMBER

• CIP: 34009 279 994 1 3

9. DATE OF FIRST AUTHORIZATION / RENEWAL

• First Authorization Date: January 9, 2015

10. DATE OF TEXT REVISION

To be completed later by the marketing authorization holder.

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

PRESCRIPTION AND DISPENSING CONDITIONS

Non-prescription medicine (Over-the-Counter).