Indications and uses
■ temporarily relieves these symptoms due to the common cold: ■ sneezing ■ nasal congestion ■ sore throat ■ headache ■ minor aches and pains ■ runny nose ■ sinus congestion and pressure ■ temporarily reduces fever
■ temporarily relieves these symptoms due to the common cold: ■ sneezing ■ nasal congestion ■ sore throat ■ headache ■ minor aches and pains ■ runny nose ■ sinus congestion and pressure ■ temporarily reduces fever
■ do not use more than directed (see overdose warning) ■ adults and children 12 years and over: take 2 tablets completely dissolved in 4 oz of water every 4 hours ■ do not take more than 8 tablets in 24 hours ■ children under 12 years: ask a doctor
(in each effervescent tablet)
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 due to the common cold:
■ sneezing ■ nasal congestion ■ sore throat
■ headache ■ minor aches and pains ■ runny nose
■ sinus congestion and pressure
■ temporarily reduces fever
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 an 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 nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for 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.
Do not use ■ 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. ■ if you ever had an allergic reaction to this product or any of its ingredients.
Ask a doctor before use if ■ 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
Ask a doctor before use if you have ■ asthma ■ glaucoma ■ diabetes ■ thyroid disease ■ trouble urinating due to an enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis ■ been placed on a sodium-restricted diet
Ask a doctor or pharmacist before use if you are ■ taking sedatives or tranquilizers ■ presently taking a prescription drug ■ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis
When using this product ■ do not exceed the recommended dosage
■ 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
Stop use and ask a doctor if ■ 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
If pregnant or breast-feeding, 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.
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 oz of water every 4 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, anhydrous citric acid, aspartame, docusate sodium, FD&C red #40, FD&C yellow #6, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate
Serious side effects assoicated with the use of this product can be reported to the following address:
Tower Laboratories LTD
8 Industrial Park Road
Centerbrook, CT 06409
or by calling the following:
1-888-228-6937
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1536840 | aspirin 325 MG / chlorpheniramine maleate 2 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | PSN | 2 |
| 1536840 | aspirin 325 MG / chlorpheniramine maleate 2 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SCD | 2 |
| 1536840 | ASA 325 MG / Chlorpheniramine Maleate 2 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SY | 2 |
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| CHLORPHENIRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d7724692-1155-4cc8-a415-22f5fc4aec35 | Product name | 6 | 20220216 |
| bde672ba-4805-28d0-1986-73543d41b412 | Product name | 2 | 20210201 |
| d17a97fa-387f-690e-d2be-0083ab044a03 | Product name | 3 | 20170725 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| f212291f-05fe-9603-fc7e-bd73e38ce1e6 | Product name | 2 | 20161129 |
| ade821ba-260a-47e2-bd89-743e27ac9906 | Product name | 1 | 20161121 |
| 182f9ab4-4ab5-c449-200f-87ce2ce8e550 | Product name | 2 | 20151105 |
| 9425d234-4ae1-4b53-adc6-8cc7af6dd657 | Product name | 1 | 20150929 |
| c6fba691-a132-4ede-95c6-f8c6bd696636 | Product name | 1 | 20150902 |
| c0200ab5-4954-454e-9676-30b741b245bd | Product name | 1 | 20150730 |
| 2a21311a-89e2-0e83-2ebd-117f9798b2b2 | Product name | 1 | 20140508 |
| 9007e8a7-ff50-f9b9-7945-f2a1deadd94e | Product name | 1 | 20140508 |
| 96c2be53-8e44-452d-56a2-d255b2f1af2d | Product name | 1 | 20140508 |
| bf8bd5f7-495f-4022-2780-7ded7ea7ea44 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50201-8752-0 | Top Value Effervescent Cold Relief - Orange | 10 in 1 CARTON | TABLET, EFFERVESCENT | 10 | 2 | |
| 50201-8752-0 | Top Value Effervescent Cold Relief - Orange | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50201-8752 | TOP VALUE EFFERVESCENT COLD RELIEF - ORANGE (ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [TOWER LABORATORIES LTD.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20241115_c6f207e8-bc0d-853a-e053-2a95a90ac623.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50201-8752 | 50201-8752-0 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PHENYLEPHRINE BITARTRATE | 27O3Q5ML57 | ACTIB |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| ASPARTAME | Z0H242BBR1 | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| ASPIRIN | R16CO5Y76E | ACTIB |
| DOCUSATE SODIUM | F05Q2T2JA0 | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| POVIDONE K30 | U725QWY32X | IACT |
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 |
|---|---|---|---|---|---|---|
| Top Value Effervescent Cold Relief - Orange | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Tower Laboratories Ltd. | c6f207e8-bc0d-853a-e053-2a95a90ac623 | 2024-11-13 | Warnings | 50201-8752-0 50201-8752 50201875200 26d1661f-fe9c-0a2a-e063-6394a90ade14 c6f207e8-bc0d-853a-e053-2a95a90ac623 |
Adverse event summaries are temporarily unavailable. Other product information remains available.