OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENT IN EACH TABLET-
Acetaminophen 500 mg
Phenylephrine HCl 5 mg
ACTIVE INGREDIENT IN EACH TABLET-
Acetaminophen 500 mg
Phenylephrine HCl 5 mg
pain reliever/fever reducer
decongestant
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 freer breathing
temporarily relieves minor aches, pains, and fever associated with: • headache • common cold • toothache • backache • muscular aches • menstrual cramps
Warnings:
Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if: • you take more than 8 tablets in 24 hours, which is the maximum daily amount • you take with other drugs containing acetaminophen (prescription or non-prescription) • you have 3 or more alcoholic drinks every day while using this product
Alergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash • If a skin reaction occurs, stop use and seek medical help right away.
Do not use:
• with any other product containing acetaminophen this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.
• more than the recommended dose
• for more than 10 days for pain unless directed by a doctor
• for more than 3 days for fever unless directed by a doctor
• 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 MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this prouct.
Ask a doctor or pharmacist before use if: • you are taking the blood thinning drug warfarin.
Stop use and ask a doctor if:
• symptoms do not improve • pain or fever persists or gets worse • new symptoms occur • redness or swelling is present • nervousness, dizziness or sleeplessness occur • symptoms do not improve within 7 days or are accompanied by fever
Ask a doctor before use if you have: • heart disease • liver disease •high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland
When using this product do not exceed recommended dose.
If pregnant or breast-feeding baby, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions:
Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours or as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor.
Children under 12 years: Consult a doctor.
Inactive Ingredients: FD&C Blue #1, microcrystalline cellulose, povidone, sodium starch glycolate, starch, and stearic acid.
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 67060-194 | 67060-194-68, 67060-194-67 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | 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 |
|---|---|---|---|---|---|---|
| f1b2a5df-5742-96d5-e053-2a95a90af523 | 97c99b40-bcd9-710b-e053-2a95a90a10a7 | 2023-01-07 | Warnings | f1b2a5df-5742-96d5-e053-2a95a90af523 97c99b40-bcd9-710b-e053-2a95a90a10a7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.