Lozenge
Stona
Dextromethorphan Hydrobromide 10 mg
Over the counterMonograph M012
The listing
- NDC product code
- 49873-301 (labeller 49873, product 301)
- Labeller
- Sato Pharmaceutical Co., Ltd.
- Brand name
- Stona
- Generic name
- dextromethorphan hydrobromide
- Dosage form
- Lozenge
- Route
- oral
- Marketing category
- OTC MONOGRAPH DRUG M012
- Marketing start
- 19 November 1995
- Listing expires
- 31 December 2026
- RxNorm concept
- 1861935
Active ingredients
| Ingredient | Strength | Other listings |
|---|---|---|
| Dextromethorphan Hydrobromide | 10 mg | 15 |
Strengths as listed in the FDA National Drug Code Directory, retrieved 4 September 2026. "Other listings" counts every other product on this site containing the same ingredient at any strength.
What the label claims
These are read from this product's own label, not assigned by us and not inferred from the ingredient.
Stated purposeCough suppressant
Stated useCough
Drug Facts, as filed
Quoted from the label FDA holds for this product. Long fields are truncated. The panel printed on the package you are holding is the one that governs.
- Active ingredient
- (in each lozenge) Dextromethorphan HBr 10mg
- Purpose
- Cough suppressant
- Uses
- temporarily relieves cough due to minor throat and bronchial irritation associated with ■a cold ■inhaled irritants
- Warnings
- Enter section text here Do not use ■this product for persistent or chronic cough such as occurs with smoking, asthema, or emphysem, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. Ask a doctor or pharmacist before use if ■you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
- Ask a doctor or pharmacist before use
- if ■you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
- If pregnant or breast-feeding
- , ask a health professional before use.
- Keep out of reach of children
- Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
- Directions
- Adults and children 12 years and older - Let 1 or 2 lozenges dissolve slowly in the mouth every 4 hours, not more than 12 lozenges in 24 hours. Children 6 years to under 12 years - Let 1 lozenge dissolve slowly in the mouth every 4 hours, not more than 6 lozenges in 24 hours. Children under 6 years - Ask a doctor ■once or twice daily, preferably morning and evening, when needed or as directed by a doctor ■start initial dosage with minimum dose, then adjust it to suit to bowel condition
- Inactive ingredients
- aspartame, cetylpyridinium chloride, flavor, glycyrrhiza, hydroxypropyl cellulose, silicon dioxide, magnesium stearate, sucrose.
Label version 6, effective 28 November 2023. Retrieved from the openFDA drug label API on 4 September 2026. Read the full label on DailyMed.
Packages
| Package NDC | Description | Listed from |
|---|---|---|
| 49873-301-01 | 1 BLISTER PACK in 1 CARTON (49873-301-01) / 12 LOZENGE in 1 BLISTER PACK | 19 November 1995 |
The package NDC adds a third segment to the product code, identifying the pack size. See how to read an NDC.
Sources for this page
Lozenges.com is a reference publication built from FDA product listings and drug labels. It is not medical advice, diagnosis or treatment, it does not recommend any product for any condition, and it is not a substitute for a pharmacist or a doctor.