Lozenge
Robitussin Medi-Soothers
Dextromethorphan Hydrobromide 5 mg, Menthol, Unspecified Form 5 mg
Over the counterMonograph M012
The listing
- NDC product code
- 0031-9307 (labeller 0031, product 9307)
- Labeller
- Haleon US Holdings LLC
- Brand name
- Robitussin Medi-Soothers
- Generic name
- dextromethorphan hydrobromide, menthol
- Dosage form
- Lozenge
- Route
- oral
- Marketing category
- OTC MONOGRAPH DRUG M012
- Marketing start
- 1 June 2023
- Listing expires
- 31 December 2026
- RxNorm concept
- 1301246
Active ingredients
| Ingredient | Strength | Other listings |
|---|---|---|
| Dextromethorphan Hydrobromide | 5 mg | 15 |
| Menthol, Unspecified Form | 5 mg | 34 |
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 suppressantOral anesthetic
Stated useSore throatMinor throat irritationCoughSore mouth, gums and canker soresCommon cold symptoms
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 5 mg Menthol 5 mg
- Purpose
- Cough suppressant Oral anesthetic
- Uses
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold occasional minor irritation, pain, sore mouth, and sore throat
- Warnings
- Sore throat warning if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly Do Not Use if you are now taking 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. Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) Stop use and ask a doctor or dentist if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Sore throat warning if sore throat is...
- Ask a doctor before use
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)
- Stop use and ask a doctor if
- Stop use and ask a doctor or dentist if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens
- If pregnant or breast-feeding
- 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 overdose, get medical help or contact a Poison Control Center right away.
- Directions
- adults and children 12 years of age and older: take 2 lozenges (one immediately after the other) every 4 hours as needed. Allow each lozenge to dissolve slowly in the mouth. do not take more than 12 lozenges in any 24-hour period, or as directed by a doctor children under 12 years of age: do not use
- Inactive ingredients
- corn syrup, elderberry juice concentrate, glycerin, natural flavors, propylene glycol, purified water, soy lecithin, sucralose, sucrose
- Other information
- or comments? call weekdays from 8 am to 6 pm EST at 1-800-245-1040
Label version 2, effective 6 April 2024. Retrieved from the openFDA drug label API on 4 September 2026. Read the full label on DailyMed.
Packages
| Package NDC | Description | Listed from |
|---|---|---|
| 0031-9307-01 | 16 LOZENGE in 1 BLISTER PACK (0031-9307-01) | 1 June 2023 |
The package NDC adds a third segment to the product code, identifying the pack size. See how to read an NDC.
Identical on the active ingredient
One other listing states exactly the same active ingredient at exactly the same strength in the same dosage form. They are not necessarily the same product: inactive ingredients, flavour and pack size differ, and this site does not compare prices.
| Product | Labeller | NDC |
|---|---|---|
| Robitussin Medi-Soothers | Haleon US Holdings LLC | 0031-9306 |
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.