Active Ingredients And Purpose
Active ingredient (in each softgel)
Dextromethorphan HBr, USP 15mg
Purpose
Cough suppressant
VALUMEDS™ ADULT LONG-LASTING COUGH RELIEF
- Set ID
- ac4d581b-4f09-40a0-a75f-d23d9c6fc0b9
- Manufacturer
- Spirit Pharmaceuticals LLC
- Effective date
- 2024-12-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- full-release
- Hydrated at
- 2026-06-01 00:43:28
Key Label Information
Uses
Use
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
Warnings
Warnings
Directions And Dosage
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 Label Information
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
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
Products
- DEXTROMETHORPHAN
NDC Codes
Ingredients
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| GELATIN | 2G86QN327L | IACT |
| SORBITOL | 506T60A25R | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
Complete SPL Sections
SPL UNCLASSIFIED SECTION
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
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
SPL UNCLASSIFIED SECTION
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
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
- XML object
- dailymed/ac4d581b-4f09-40a0-a75f-d23d9c6fc0b9/292d3e11-ff81-09e5-e063-6394a90a0194.xml
- XML SHA-256
- e3c25995a5e97ec486b9a1ebe0c1104c50b635b9f5aabb07023682cc3ed25c2c
- XML bytes
- 26201
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 292d3e11-ff81-09e5-e063-6394a90a0194.xml | 2024-12-15 |
| otc | 0bf1fc02-10a4-522b-e063-6294a90a15f1.xml | 2023-12-08 |
| otc | ee8b53ae-4501-651f-e053-2a95a90ab4dd.xml | 2022-11-29 |
| otc | d21895dd-5bc3-4868-e053-2a95a90a432f.xml | 2021-12-02 |
| otc | 15 ct.jpg | 2020-03-17 |
| otc | 240 ct.jpg | 2020-03-17 |
| otc | 60 ct.jpg | 2020-03-17 |
| otc | a0fb9b39-907a-3f0b-e053-2a95a90a8aac.xml | 2020-03-17 |
| otc | a0ab9824-5e44-6f8f-e053-2a95a90a72e6.xml | 2020-03-13 |
| otc | DEXTROM 15CT.jpg | 2020-03-13 |
| otc | DEXTROM 240 CT_N.jpg | 2020-03-13 |
| otc | 9aa388ef-c503-482c-e053-2995a90af440.xml | 2019-12-27 |
| otc | 6999b5db-104c-cf46-e053-2a91aa0a4ef6.xml | 2018-04-12 |
| otc | DEXTRO.jpg | 2018-04-12 |