Indications and uses
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
Adult Long Lasting Cough Relief
- Manufacturer
- Shield Pharmaceuticals Corp
- Effective date
- 2025-11-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:43:20
Label at a glance#
ProductAdult Long Lasting Cough Relief
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE
Label structure11 sections
Dosage and administration
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 softgels every 6 to 8 hours, as needed children under 12 years do not use
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each softgel)
Dextromethorphan HBr, USP 15 mg
Purpose
Cough suppressant
Uses
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
Warnings
OTC - DO NOT USE SECTION
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.
OTC - ASK DOCTOR SECTION
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
OTC - STOP USE SECTION
Stop use and ask a doctor ifcough 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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding,ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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 softgels every 6 to 8 hours, as needed |
| children under 12 years | do not use |
Other information
• store at controlled room temperature 20-25ºC (68-77ºF)
• avoid excessive heat above 40°C (104°F)
• protect from light
Questions or comments?
1-800-373-6981 (toll-free)
Inactive ingredients
FD&C blue no. 1, FD&C red no. 40, FD&C yellow 6, gelatin, glycerin, polyethylene glycol 400, povidone (pvp k 30), propylene glycol, purified water, sorbitan, sorbitol solution*. *may contain this inactive ingredient
SPL UNCLASSIFIED SECTION
Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779
PRINCIPAL DISPLAY PANEL
ValuRx
Compare to the active ingredient in Robitussin® Long-Acting Coughgels®†
Up to 8 Hr. Relief
Adult Long-Lasting
Cough Relief
Dextromethorphan HBr
(Cough Suppressant)
Carton
Label
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0611419406194 | GTIN-13: 0611419406194 EAN-13: 0611419406194 GTIN-12: 611419406194 UPC-A: 611419406194 GTIN storage (14 digits): 00611419406194 | Carton.jpg |
| QR code link | QR Code |  www.shieldpharmacorp.com/ | Carton.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83059-0110-8 | Adult Long Lasting Cough Relief | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | 2 | |
| 83059-0110-8 | Adult Long Lasting Cough Relief | 15 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 15 | 2 |
Products#
Every source-derived product name is available through these pages.
- Adult Long Lasting Cough Relief
- Dextromethorphan HBr
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- GELATIN
- GLYCERIN
- POLYETHYLENE GLYCOL 400
- POVIDONE
- PROPYLENE GLYCOL
- SORBITAN
- WATER
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 83059-0110 | 83059-0110-8 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POVIDONE | FZ989GH94E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| WATER | 059QF0KO0R | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 58785025-4add-a1e5-e063-6294a90aa5af | 8e93923e-d428-490f-8f68-1c0696e63ace | 2026-08-07 | Warnings | 8e93923e-d428-490f-8f68-1c0696e63ace |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.