OTC - ACTIVE INGREDIENT SECTION
Active Ingredient (in each tablet) Acetaminophen 325 mg, Phenylephrine HCL-Nasal Decongestant
Active Ingredient (in each tablet) Acetaminophen 325 mg, Phenylephrine HCL-Nasal Decongestant
Purpose-Pain Reliever Nasal Decongestant
Uses temporarily relieves the following cold and hay fever symptoms:
■ nasal and sinus congestion ■ sinus pain ■ headache ■ minor aches and pains
Warnings
Directions
■ adults: take 2 tablets every 4 hours, not more than 12 tablets in 24 hours
Children under 12 years, ask a doctor
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
■ more than 12 tablets in 24 hours, which is the maximum daily amount
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while using this product
Do not use
■ 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 do not know if your
prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains
acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if you have
■ heart disease ■ high blood pressure ■ diabetes ■ thyroid disease ■ liver disease
■ trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Stop use and ask a doctor if
■ you get nervous, dizzy or sleepless
■ pain or nasal congestion gets worse or lasts more than 7 days
■ redness or swelling is present in the painful area
■ any new symptoms appear
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.
Inactive Ingredients:corn starch, FDC blue 1 aluminum lake, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 42961-052 | 42961-052-01, 42961-052-02, 42961-052-03 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POVIDONE K29/32 | 390RMW2PEQ | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | 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 |
|---|---|---|---|---|---|---|
| ebaab830-ee5b-40ea-93c5-2fb2123e1d9c | bf0dd115-67b8-4c05-9fae-9e255a611399 | 2022-12-30 | Warnings | bf0dd115-67b8-4c05-9fae-9e255a611399 |
Adverse event summaries are temporarily unavailable. Other product information remains available.