WARNINGS SECTION
Warnings
Warnings
Purpose: Bronchodilator, Expectorant
Uses for temporary relief of mild symptoms of intermittent asthma: wheezing
tightness of chest , shortness of breath , helps loosen phlegm (mucus) and thin
bronchial secretions to rid bronchial passageways of bothersome mucus, and to make
coughs more productive
Keep out of reach of children. In case of overdose, get
medical help or contact a Poison Control Center right away.
If pregnant or breast-feeding, ask a health
professional before use
Directions do not take more than directed
adults and children 12 years of age and over: take 1
bottle every 4 hours as needed. Do not take more than
6 bottles in 24 hours children under 12 years of age:
do not use
Inactive ingredients Blue #1, Citric Acid,
Filtered Water, Malic Acid, Natural and Artificial Flavors,
Potassium Sorbate, Propylene Glycol, Sodium
Ephedrine HCI 25 mg, Bronchodilator
Guaifenesin 400 mg, Expectorant
| Class | Version | Type | Effective |
|---|---|---|---|
| EPHEDRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d1bd959e-e326-44fb-b8ca-8c56a84a2a3d | Product name | 2 | 20251211 |
| f1d178e1-1663-4c63-ae37-62a1b322fba4 | Product name | 2 | 20251106 |
| f606d3ac-dd63-4b29-bea0-db23753b8ddc | Product name | 1 | 20220118 |
| 30254138-2d98-4aa2-8e07-ae82e8b0a389 | Product name | 3 | 20171103 |
| fee762de-ffd9-404d-8bc6-8c0c208e758d | Product name | 1 | 20170426 |
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 65193-180-57 | 2023-01-30 | C162847 | 48780-1 | f386c649-abb9-0266-e053-dadaa90a7c1a | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65193-180-57 | Ephed Plus Liquid | 60 mL in 1 BOTTLE | LIQUID | 60 | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 65193-180 | 65193-180-57 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| EPHEDRINE HYDROCHLORIDE | NLJ6390P1Z | ACTIB |
| guaifenesin | 495W7451VQ | ACTIB |
| WATER | 059QF0KO0R | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| POTASSIUM SORBATE | 1VPU26JZZ4 | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| MALIC ACID | 817L1N4CKP | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
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 |
|---|---|---|---|---|---|---|
| 829e7118-dad3-495a-b5d8-4f3b2b9d5d32 | e12ffea3-29f9-4748-92ed-dfcf91f5a0c2 | 2019-04-02 | Warnings | 829e7118-dad3-495a-b5d8-4f3b2b9d5d32 e12ffea3-29f9-4748-92ed-dfcf91f5a0c2 |
Adverse event summaries are temporarily unavailable. Other product information remains available.