FDA Label for Pain Relief Fast Relief
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- REYE'S SYNDROME
- ALLERGY ALERT
- STOMACH BLEEDING WARNING
- ALCOHOL WARNING
- OTC - DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF
- OTC - WHEN USING
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL - 36 TABLET CARTON
Pain Relief Fast Relief Product Label
The following document was submitted to the FDA by the labeler of this product Select Brand. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Aspirin may cause stomach bleeding.
Distributed by
select brand® /SAJ Distributors
3017 N. Midland Drive
Pine Bluff, AR 71603
Otc - Purpose
Active ingredients (in each effervescent tablet) | Purpose |
---|---|
Aspirin (NSAID) nonsteroidal anti-inflammatory drug 325 mg | Pain reliever |
Citric acid 1000 mg | Antacid |
Sodium bicarbonate (heat-treated) 1916 mg | Antacid |
Uses
For the temporary relief of: heartburn, acid indigestion, and sour stomach when accompanied with headache or body aches and pains
- upset stomach with headache from overindulgence in food or drink
- headache, body aches and pain alone
Reye's Syndrome
Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.
Allergy Alert
Aspirin may cause a sever 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 other drugs containing prescription or nonprescription NSAID's (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
Alcohol Warning
If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers.
Otc - Do Not Use
Do not use: if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer
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
- you have asthma
- you have a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If
- you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.
- you are taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis.
Otc - When Using
When using this product do not exceed the recommended dosage
Stop Use And Ask A Doctor If
- an allergic reaction occurs. Seek medical help right away.
- 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
- symptoms get worse or last more than 10 days
- new symptoms occur
- redness or swelling is present
- ringing in the ears or a loss of hearing occurs
Otc - Pregnancy Or Breast Feeding
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- Dissolve tablets in 4 ounces of water before taking
- 2 tablets every 4 hours, or as directed by a doctor
- do not exceed 8 tablets in 24 hours
- 2 tablets every 4 hours, or as directed by a doctor
- do not exceed 4 tablets in 24 hours
Adults and Children 12 Years and over | |
60 Years and over |
Other Information
- Each tablet contains: sodium 540 mg
- store at room temperature. Avoid excessive heat
- in water, this tablet contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate
Inactive Ingredients
None
Principal Display Panel - 36 Tablet Carton
NDC 15127-968-36
select brand®
the lower price name brand
FAST RELIEF
EFFERVESCENT
Pain Relief
Aspirin (NSAID) / Pain reliever,
Citric acid / Antacid, Sodium bicarbonate / Antacid.
Relieves:
Heartburn • Acid Indigestion
• Sour Stomach with
Headache
• Body Aches
and Pain
Compare to Active
Ingredients in
Alka-Seltzer®*
36 EFFERVESCENT
TABLETS
* Please review the disclaimer below.