OTC - ACTIVE INGREDIENT SECTION
Active Ingredients
Acetaminophen 325 mg.......................Pain Reliever/Fever ReducerPhenylephrine HCl 5 mg.............................Nasal Decongestant
Active Ingredients
Acetaminophen 325 mg.......................Pain Reliever/Fever ReducerPain Reliever, Fever Reducer, Nasal Decongestant
Directions: Adults and children 12 years of age and older: • Take 2 tablets every 4
to 6 hours as needed, do not exceed 8 tablets in 24 hours, or
as directed by a doctor. • Children under 12 years : Consult a
doctor
Uses: Temporarily: • relieves nasal congestion associated
with sinusitis • relieves nasal congestion due to the common
cold, hay fever or other upper respiratory allergies • relieves
sinus congestion and pressure ,helps decongest sinus
openings and passages • restores free breathing. Temporarily
relieves minor aches, pains, and fever associated with:
• headache • common cold • toothache • backache • muscular
aches • menstrual cramps
If pregnant or breast-feeding baby, ask a health professional
before use.
KEEP OUT OF REACH OF CHILDREN.
Inactive Ingredients: corn starch, FDC Blue 1, maltodextrin,
microcrystalline cellulose, polyethylene glycol, povidone, sodium
starch glycolate, and stearic acid
MM1
| Class | Version | Type | Effective |
|---|---|---|---|
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52904-493-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6700-f424-e053-dadaa90a57ce | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52904-493-02 | Sinus Relief Headache Nasal | 2 in 1 PACKET | TABLET | 2 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 52904-493 | 52904-493-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | 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 K30 | POVIDONE K30 | U725QWY32X | POWDER / ORAL | 378 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | POWDER, FOR SUSPENSION / ORAL | 1203 mg/5ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM / SUBLINGUAL | 0.07 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SYRUP / ORAL | 0.05 mg/5ml | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SUSPENSION, EXTENDED RELEASE / ORAL | 474 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 45 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SOLUTION / ORAL | 690 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SHAMPOO / TOPICAL | 0.75 %w/w | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET / BUCCAL | 1 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, EXTENDED RELEASE / ORAL | 368 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / RECTAL | 0.01 %w/v | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE / ORAL | 1725 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SHAMPOO / TOPICAL | 9.7 %w/w | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, FILM COATED / ORAL | 245 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / DENTAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 580 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE, DELAYED RELEASE / ORAL | 227 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / VAGINAL | 4 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SUSPENSION / ORAL | 1 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SUSPENSION / OPHTHALMIC | 14 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, EXTENDED RELEASE / ORAL | 1246 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | DOUCHE / VAGINAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, DELAYED RELEASE / ORAL | 789.6 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CONCENTRATE / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / TOPICAL | 8 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE, DENTIFRICE / DENTAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, EXTENDED RELEASE / ORAL | 184 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 1576 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, DELAYED RELEASE / ORAL | 516 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | PASTILLE / ORAL | NA | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 15 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / TOPICAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE / ORAL | 26.3 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE / ORAL | 29520 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / SUBLINGUAL | 409 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SUSPENSION / ORAL | 148 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE, LIQUID FILLED / ORAL | 101 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING / ORAL | 100 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, FILM COATED / ORAL | 2000 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / BUCCAL | 6 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | POWDER, FOR SUSPENSION / ORAL | 257 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOAP / TOPICAL | 6 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, LIQUID FILLED / ORAL | 0.08 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, COATED / ORAL | 256 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED PELLETS / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / SUBLINGUAL | 0.03 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SUSPENSION / ORAL | 1 mg/5ml | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IMPLANT / INTRAVITREAL | 1.66 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 |
|---|---|---|---|---|---|---|
| ae5d9540-a988-4072-9a46-b2bfcb4fd3a1 | 1d975dea-6135-4560-b62e-fa31109fd002 | 2012-10-15 | Warnings | ae5d9540-a988-4072-9a46-b2bfcb4fd3a1 1d975dea-6135-4560-b62e-fa31109fd002 |
Adverse event summaries are temporarily unavailable. Other product information remains available.