OTC - ACTIVE INGREDIENT SECTION
Active ingredient - (per tablet) - Purpose
Dextromethorphan Hydrobromide 20mg Cough Suppressant
Guaifenesin 400mg Expectorant
Active ingredient - (per tablet) - Purpose
Dextromethorphan Hydrobromide 20mg Cough Suppressant
Guaifenesin 400mg Expectorant
Ask doctor before use if you have
persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysma
cough is accompanied by excessive phlegm (mucous)
Stop use and ask doctor if
Symptoms are accompanied by fever, rash or persistent headache
cough persists for more than 1 week or tends to recur
A persistent cough may be a sign of a serious condition
Do not use if you are now taking a prescription monoamine oxidase (inhiMor~MAIO)
Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease
or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains
an MAIO, ask your doctor or pharmacist before using this product.
Keep out of reach of children, In ase of overdose, get medical help or contact a Poison Center immediately
If pregnant or breastfeeding, ask a health professional before use.
magnesium stearate, microcrystalline cellulose,
May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium
phosphate, maltodextrin, sodium starch glycolate, stearic acid
Directions
• Adults and children 12 years of age and over:
take 1 tablet every 4 hours as needed
• Children 610 under 12 years of age: take 1/2 tablet every 4 hours as needed
• Children under 6 years of age: consult a doctor
Do not exceed 6 doses in a 24 hour period or as directed by a doctor
Other information store at 15'- 30' C (59'- 86'F) Rev 10/U9 RCCF
Uses. temporarily relieves cough due to minor throat and bronchial irritation
as may occur with a common cold • helps loosen phlegm (mucus) and thin
bronchial secretions to rid the bronchial passageways of bothersome mucus
• helps make coughs more productive
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| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| 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 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10956-761-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-1402-f424-e053-dadaa90a57ce | drug facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10956-761-01 | Freds Chest Congestion ReliefDM | 1 in 1 CARTON | TABLET | 1 | 126 | |
| 10956-761-50 | Freds Chest Congestion ReliefDM | 50 in 1 BOTTLE, PLASTIC | TABLET | 50 | 126 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10956-761-50 | EA - Each | 10956-761 | 0b71f6f4-7473-4c55-bd2a-472905e35bf2 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 126 | |
| Guaifenesin | ACTIVE INGREDIENT | 495W7451VQ | 126 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 126 | |
| Guaifenesin | ACTIVE MOIETY | 495W7451VQ | 126 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 10956-761 | 10956-761-50, 10956-761-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| Guaifenesin | 495W7451VQ | ACTIB |
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 |
|---|---|---|---|---|---|---|
| 7a7843e4-292f-4bcf-8dfb-d0973f3407aa | 98e6d6ba-4164-4a14-b186-a5016c7e4c33 | 2010-07-30 | 7a7843e4-292f-4bcf-8dfb-d0973f3407aa 98e6d6ba-4164-4a14-b186-a5016c7e4c33 |
Adverse event summaries are temporarily unavailable. Other product information remains available.