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 oz 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
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
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 nonsteroidal 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 nonprescription 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. ■ you are taking sedatives or tranquilizers. You have ■ 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
■ 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 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.
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 4-6 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
Or to report an adverse event call
800-824-1706 Monday - Friday
9am - 4pm MST
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1536840 | aspirin 325 MG / chlorpheniramine maleate 2 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | PSN | 4 |
| 1536840 | aspirin 325 MG / chlorpheniramine maleate 2 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SCD | 4 |
| 1536840 | ASA 325 MG / Chlorpheniramine Maleate 2 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet | SY | 4 |
| 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 |
|---|---|---|---|---|---|---|
| 67091-109-20 | WinCo Foods Effervescent Cold Relief | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 4 | |
| 67091-109-20 | WinCo Foods Effervescent Cold Relief | 10 in 1 CARTON | TABLET, EFFERVESCENT | 10 | 4 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67091-109 | WINCO FOODS EFFERVESCENT COLD RELIEF (ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE) TABLET, EFFERVESCENT [WINCO FOODS, LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241115_d443a030-d3d6-40e0-8fe0-329de6bc494f.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ASPIRIN | ACTIVE INGREDIENT | R16CO5Y76E | 1 | |
| CHLORPHENIRAMINE MALEATE | ACTIVE INGREDIENT | V1Q0O9OJ9Z | 1 | |
| PHENYLEPHRINE BITARTRATE | ACTIVE INGREDIENT | 27O3Q5ML57 | 1 | |
| ASPIRIN | ACTIVE MOIETY | R16CO5Y76E | 1 | |
| CHLORPHENIRAMINE | ACTIVE MOIETY | 3U6IO1965U | 1 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| ACESULFAME POTASSIUM | INACTIVE INGREDIENT | 23OV73Q5G9 | 1 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| DOCUSATE SODIUM | INACTIVE INGREDIENT | F05Q2T2JA0 | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| SODIUM BICARBONATE | INACTIVE INGREDIENT | 8MDF5V39QO | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 67091-109 | 67091-109-20 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| ASPARTAME | Z0H242BBR1 | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| DOCUSATE SODIUM | F05Q2T2JA0 | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| ASPIRIN | R16CO5Y76E | ACTIB |
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| PHENYLEPHRINE BITARTRATE | 27O3Q5ML57 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | ELIXIR / ORAL | 5.02 mg/5ml | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, DELAYED RELEASE / ORAL | 639 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SOLUTION / ORAL | 869 mg | ||
| DOCUSATE SODIUM | DOCUSATE SODIUM | F05Q2T2JA0 | TABLET, COATED / ORAL | 1 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | WAFER / ORAL | 642 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, ORALLY DISINTEGRATING / ORAL | 71 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | POWDER, FOR SOLUTION / ORAL | 2832 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, FOR SUSPENSION / ORAL | 7621 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | GRANULE, FOR SUSPENSION / ORAL | 420 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | LOZENGE / ORAL | 136 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SUSPENSION / ORAL | 148 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | CAPSULE, DELAYED RELEASE / ORAL | 2043 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | POWDER / ORAL | 378 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET / ORAL | 3391 mg | ||
| DOCUSATE SODIUM | DOCUSATE SODIUM | F05Q2T2JA0 | SUSPENSION, EXTENDED RELEASE / ORAL | 0.77 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | GRANULE / ORAL | 202 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, FOR SUSPENSION / ORAL | 7621 mg | ||
| DOCUSATE SODIUM | DOCUSATE SODIUM | F05Q2T2JA0 | SUSPENSION / ORAL | 48 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, EXTENDED RELEASE / ORAL | 368 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE, EXTENDED RELEASE / ORAL | 120 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SYRUP / ORAL | 80 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | PASTE / ORAL | 28 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | POWDER, FOR SUSPENSION / ORAL | 420 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | WAFER / ORAL | 642 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, DELAYED RELEASE / ORAL | 0.34 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | CAPSULE, EXTENDED RELEASE / ORAL | 3 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, COATED / ORAL | 0.2 mg | ||
| SODIUM BICARBONATE | SODIUM BICARBONATE | 8MDF5V39QO | TABLET, EFFERVESCENT / ORAL | 57600 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TROCHE / ORAL | 14594 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, COATED / ORAL | 160 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 178 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | POWDER, FOR SOLUTION / ORAL | 233 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | GRANULE, EFFERVESCENT / ORAL | 30 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | GRANULE, EFFERVESCENT / ORAL | 40 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SOLUTION / ORAL | 300 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, ORALLY DISINTEGRATING / ORAL | 180 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, ORALLY DISINTEGRATING / ORAL | 4364 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, FOR SUSPENSION / ORAL | 462 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | CAPSULE, DELAYED RELEASE / ORAL | 227 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | GRANULE, FOR SUSPENSION / ORAL | 120 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| DOCUSATE SODIUM | DOCUSATE SODIUM | F05Q2T2JA0 | CAPSULE, EXTENDED RELEASE / ORAL | NA | ||
| MANNITOL | MANNITOL | 3OWL53L36A | GRANULE, FOR SUSPENSION / ORAL | 6000 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | SUSPENSION, EXTENDED RELEASE / ORAL | 474 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, CHEWABLE / ORAL | 3726 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 1568 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, FILM COATED / ORAL | 245 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, COATED / ORAL | 177.7 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, CHEWABLE / ORAL | 195 mg | ||
| DOCUSATE SODIUM | DOCUSATE SODIUM | F05Q2T2JA0 | CAPSULE, EXTENDED RELEASE / ORAL | NA | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 78 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | CAPSULE / ORAL | 1562 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | SOLUTION / ORAL | 40 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET, ORALLY DISINTEGRATING / ORAL | 71 mg | ||
| DOCUSATE SODIUM | DOCUSATE SODIUM | F05Q2T2JA0 | TABLET / ORAL | 50 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GRANULE, EFFERVESCENT / ORAL | 60 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, FILM COATED / ORAL | 20 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SYRUP / ORAL | 80 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 543 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 |
|---|---|---|---|---|---|---|
| WinCo Foods Effervescent Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE | WinCo Foods, LLC | d443a030-d3d6-40e0-8fe0-329de6bc494f | 2024-11-13 | Warnings | 67091-109-20 67091-109 67091010920 26d1b568-ad98-80d7-e063-6394a90a2cbf d443a030-d3d6-40e0-8fe0-329de6bc494f |
Adverse event summaries are temporarily unavailable. Other product information remains available.