Indications and uses
temporarily relieves these symptoms of the common cold: ■ fever ■ sneezing ■ nasal congestion ■ sore throat ■ headache ■ minor aches and pains ■ runny nose ■ sinus congestion and pressure
temporarily relieves these symptoms of the common cold: ■ fever ■ sneezing ■ nasal congestion ■ sore throat ■ headache ■ minor aches and pains ■ runny nose ■ sinus congestion and pressure
■ do not use more than directed (see overdose warning) ■ adults and children 12 years and over: take 2 tablets completely dissolved in 4 ounces of water every 4-6 hours ■ do not take more than 8 tablets in 24 hours ■ children under 12 years: ask a doctor
Aspirin 325 mg NSAID*
Chlorpheniramine maleate 2 mg
Phenylephrine bitartrate 7.8 mg
*Nonsteroidal anti-inflammatory drug
Aspirin 325 mg NSAID*. . . . . . . . . . . . . . . . . . .Pain reliever/fever reducer
Chlorpheniramine maleate 2 mg . . . . . . . . . . . ..Antihistamine
Phenylephrine bitartrate 7.8 mg . . . . . . . . . . . . .Nasal decongestant
*Nonsteroidal anti-inflammatory drug
temporarily relieves these symptoms of the common cold:
■ fever ■ sneezing ■ nasal congestion ■ sore throat ■ headache
■ minor aches and pains ■ runny nose
■ sinus congestion and pressure
Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction which may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock
Stomach bleeding warning: This product contains a non-steroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you
■ are age 60 or older ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time than directed
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
■ if you have ever had an allergic reaction to any other pain reliever/fever reducer
■ if you are allergic to aspirin ■ 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.
■ stomach bleeding warning applies to you ■ you have a history of stomach problems such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you are taking a diuretic ■ glaucoma ■ diabetes ■ thyroid disease ■ trouble urinating due to an enlarged prostate glad ■ a breathing problem such as emphysema or chronic bronchitis ■ been placed on a sodium-restricted diet.
■ presently taking a prescription drug ■ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis
■ do not take more than 8 tablets (adults and children 12 years and over) in a 24-hour period or as directed by a doctor.
■ do not use more than directed
■ you may get drowsy
■ avoid alcoholic drinks
■ excitability may occur, especially in children
■ alcohol, sedatives and tranquilizers may increase drowsiness
■ be careful when driving a motor vehicle or operating machinery
■ you experience any of the following signs of stomach bleeding
■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better
■ an allergic reaction occurs. Seek medical help right away.
■ pain or nasal congestion gets worse or lasts more than 7 days
■ fever gets worse or lasts more than 3 days
■ new symptoms occur
■ redness or swelling is present
■ ringing in the ears or a loss of hearing occurs
■ nervousness, dizziness or sleeplessness occurs
ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
■ do not use more than directed (see overdose warning)
■ adults and children 12 years and over: take 2 tablets completely dissolved in 4 ounces of water every 4-6 hours
■ do not take more than 8 tablets in 24 hours
■ children under 12 years: ask a doctor
each tablet contains:
sodium 464 mg
■ phenylketonurics: contains phenylalanine 9 mg per tablet
■ store at room temperature (59°-86°F)
acesulfame potassium, aspartame, citric acid, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 46122-063 | 46122-063-60 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PHENYLEPHRINE BITARTRATE | 27O3Q5ML57 | ACTIB |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| ASPARTAME | Z0H242BBR1 | IACT |
| DOCUSATE SODIUM | F05Q2T2JA0 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| ASPIRIN | R16CO5Y76E | 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 |
|---|---|---|---|---|---|---|
| b4c9e6fd-af06-e3f6-e053-2a95a90ac877 | 68a6518f-8143-2bcd-e053-2a91aa0a2256 | 2020-11-23 | Warnings | b4c9e6fd-af06-e3f6-e053-2a95a90ac877 68a6518f-8143-2bcd-e053-2a91aa0a2256 |
Adverse event summaries are temporarily unavailable. Other product information remains available.