Indications and uses
■ heartburn, acid indigestion and sour stomach when accompanied by headache or body aches and pains ■ upset stomach with headache from overindulgence in food or drink ■ pain alone (headaches or body aches and pains)
■ heartburn, acid indigestion and sour stomach when accompanied by headache or body aches and pains ■ upset stomach with headache from overindulgence in food or drink ■ pain alone (headaches or body aches and pains)
(in each tablet)
Aspirin 325 mg (NSAID)*
Citric acid 1000 mg
Sodium bicarbonate (heat-treated) 1916 mg
*Nonsteroidal anti-inflammatory drug
Aspirin 325 mg (NSAID)*. . . . . . . . . . . . . . . . . . . . . .Pain reliever
Citric acid 1000 mg . . . . . . . . . . . . . . . . . . . . . .. . . . Antacid
Sodium bicarbonate (heat-treated) 1916 mg . . . . . . Antacid
*Nonsteroidal anti-inflammatory drug
■ heartburn, acid indigestion and sour stomach when accompanied by headache or body aches and pains
■ upset stomach with headache from overindulgence in food or drink
■ pain alone (headaches or body aches and pains)
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
■ if you have ever had an allergic reaction to any other pain reliever/fever reducer
■ if you are allergic to aspirin ■ if overly full from food or drink. Ask a doctor if severe stomach pain occurs after 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 have a sodium-restricted diet
■ presently taking a prescription drug. Antacids may interact with certain prescription drugs.
■ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis
do not take more than 8 tablets (adults) or 4 tablets (60 years and over) in a 24-hour period or use the maximum dosage for more than 10 days
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 lasts for more than 10 days or gets worse
■ new symptoms occur
■ redness or swelling is present
■ ringing in the ears or a loss of hearing 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.
Directions
■ do not exceed recommended dosage
■ to avoid serious injury, completely dissolve tablets in 4 oz. of water before taking
■ adults and children 12 years and over (up to 60 years of age): 2 tablets every 4 hours - do not exceed 8 tablets in 24 hours
■ 60 years and over: 2 tablets every 4 hours - do not exceed 4 tablets in 24 hours
■ each tablet contains: sodium 524 mg
■ store at room temperature (59º-86ºF)
■ none
Serious side effects associated with the use of this product can be reported to the following address:
Distributed by: Midwood Brands, LLC
10611 Monroe Rd, Matthews, NC 28105
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55319-421 | 55319-421-36, 55319-421-24 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ASPIRIN | R16CO5Y76E | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | ACTIB |
| SODIUM BICARBONATE | 8MDF5V39QO | 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 |
|---|---|---|---|---|---|---|
| d1176553-b6d1-0d33-e053-2a95a90a0e9b | 60b5bef5-4c92-e07a-e053-2991aa0a193a | 2021-11-18 | Warnings | d1176553-b6d1-0d33-e053-2a95a90a0e9b 60b5bef5-4c92-e07a-e053-2991aa0a193a |
Adverse event summaries are temporarily unavailable. Other product information remains available.