Temporarily relieves symptoms associated with a cough ,the common cold,hay fever or other upper respiratory allergies. ■ helps loosen phlegm (mucus) ■ clear nasal passageways ■ loosens nasal congestion ■ drain bronchial tubes ■ shrinks swollen membranes ■ clears stuffy nose ■ makes coughs more productive
■ adults and children 12 years and over: take 1 caplet every 4 hours as needed ■ children 6 to under 12 years: take 1/2 caplet every 4 hours as needed ■ children under 6 years: consult a doctor Do not exceed 6 doses in a 24 hour period or as directed by a doctor.
Active ingredient - (per tablet)
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
Guaifenesin.......................Expectorant
Phenylephrine HCl..............Nasal decongestant
Temporarily relieves symptoms associated with a cough ,the common cold,hay fever or other upper respiratory allergies.
■ helps loosen phlegm (mucus)
■ clear nasal passageways
■ loosens nasal congestion
■ drain bronchial tubes
■ shrinks swollen membranes
■ clears stuffy nose
■ makes coughs more productive
Do not exceed recommended dosage
■ this product 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 are uncertain whether your prescription drug contains an MAOI, ask a health
professional.
■ heart disease
■ high blood pressure
■ thyroid disease
■ diabetes
■ excessive phlegm;mucus
■ difficulty in urination due to an enlarged prostate gland
■ persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis or emphysema
■ nervousness, dizziness or sleeplessness occurs
■ symptoms are accompanied by fever, rash,
persistent headache or excessive phlegm (mucus)
■ cough and congestion do not improve within 7 days
or tend to recur.
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health
professional before use.
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison
Control Center immediately.
■ adults and children 12 years and over:
take 1 caplet every 4 hours as needed
■ children 6 to under 12 years:
take 1/2 caplet every 4 hours as needed
■ children under 6 years: consult a doctor
Do not exceed 6 doses in a 24 hour period or as directed by a doctor.
lactose, magnesium silicate,
croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin,
microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid,
titanium dioxide and triacetin
| Class | Version | Type | Effective |
|---|---|---|---|
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49348-774-09 | Sunmark Chest Congestion Relief PEPE | 1 in 1 CARTON | TABLET | 1 | 4 | |
| 49348-774-09 | Sunmark Chest Congestion Relief PEPE | 50 in 1 BOTTLE | TABLET | 50 | 4 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49348-774-09 | EA - Each | 49348-774 | eac4436c-69b7-407d-9dff-5cfe4755e476 | 1 | 2014-05-02 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Guaifenesin | ACTIVE INGREDIENT | 495W7451VQ | 1 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| Guaifenesin | ACTIVE MOIETY | 495W7451VQ | 1 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | 1 | |
| MAGNESIUM SILICATE | INACTIVE INGREDIENT | 9B9691B2N9 | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 49348-774 | 49348-774-09 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Guaifenesin | 495W7451VQ | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| LACTOSE | J2B2A4N98G | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| POVIDONE | FZ989GH94E | IACT |
| MAGNESIUM SILICATE | 9B9691B2N9 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| POVIDONE | POVIDONE | FZ989GH94E | TABLET / ORAL | 216 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET / ORAL | 2500 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET / ORAL | 2500 mg | ||
| MAGNESIUM SILICATE | MAGNESIUM SILICATE | 9B9691B2N9 | TABLET / ORAL | 10 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | TABLET / ORAL | 320 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET / ORAL | 216 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET / ORAL | 113.75 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET / ORAL | 113.75 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | TABLET / ORAL | 320 mg | ||
| MAGNESIUM SILICATE | MAGNESIUM SILICATE | 9B9691B2N9 | TABLET / ORAL | 10 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg |
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 |
|---|---|---|---|---|---|---|
| Sunmark Chest Congestion Relief PE PE | GUAIFENESIN/PHENYLEPHRINE | Strategic Sourcing Services LLC | f94ae469-4c79-4ce9-9a3d-3bdc645be6d9 | 2024-12-18 | Warnings | 49348-774-09 49348-774 49348077409 06fe6676-29a9-4deb-aa91-b28365e68afb f94ae469-4c79-4ce9-9a3d-3bdc645be6d9 |
Adverse event summaries are temporarily unavailable. Other product information remains available.