DEXTROMETHORPHAN HYDROBROMIDE
- Dosage form
- CAPSULE, LIQUID FILLED
- Labeler
- Spirit Pharmaceuticals LLC
- Label updated
- 2024-12-13
- Retrieved
- 2026-09-07
- Active ingredients
- DEXTROMETHORPHAN HYDROBROMIDE
Label information
Drug Facts
Active ingredient (in each softgel)
Dextromethorphan HBr, USP 15mg
Purpose
Cough suppressant
Use
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
Warnings
Label information
Do not 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
Ask a doctor before use if you have
- a cough that occurs with too much phlegm (mucus)
- a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema
Label information
Stop use and ask doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Label information
If pregnant or breast-feeding, ask a health professional before use.
Label information
Keep out of reach of children. In case of overdose, get medical help orcontact a Poison Control Center right away.
Directions
- do not take more than 8 softgels in any 24-hour period
- this adult product is not intended for use in children under 12 years of age
| adults and children 12 years and over | take 2 capsules every 6 to 8 hours, as needed |
| children under 12 years | do not use |
Other information
- store at 20-25°C (68-77°F)
- avoid excessive heat above 40°C (104°F)
- protect from light
Inactive ingredients
FD&C red no. 40, gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone, sorbitol sorbitan, titanium dioxide
Questions or comments?
1-888-333-9792
Label information
Distributed By:
SPIRIT PHARMACEUTICALS LLC.
RONKONKOMA, NY 11779
PRINCIPAL DISPLAY PANEL
Compare to the Active Ingredient of
ROBITUSSIN ® LONG ACTING COUGH GELS ©*
VALUMEDS™
ADULT LONG-LASTING
Cough Relief FOR AGES 12 & OVER
Dextromethorphan HBr, 15 mg
Cough suppressant
Relieves cough for up to 8 hours
[Image in the official label — see DailyMed source]
[Image in the official label — see DailyMed source]
DailyMed Set ID: ac4d581b-4f09-40a0-a75f-d23d9c6fc0b9 · Version 8
NDC: 68210-0106