FDA Label for Effervescent Pain Relief

View Indications, Usage & Precautions

Effervescent Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Western Family Foods, Inc.. 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

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. Aspirin may cause stomach bleeding.

Proudly Distributed by
Western Family Foods, Inc.
P.O. Box 4057, Portland, OR 97208 U.S.A.


Otc - Purpose



Active ingredients (in each effervescent tablet)Purpose
Aspirin (NSAID)

nonsteroidal anti-inflammatory drug

325 mg
Pain reliever
Citric acid 1000 mgAntacid
Sodium bicarbonate (heat-treated) 1916 mgAntacid

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 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 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

Do Not Use If



  • you have ever had an allergic reaction to any other pain reliever/fever reducer
  • you are allergic to aspirin

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 Or Pharmacist Before Use If



  • 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

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 have 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
    • 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

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



  • completely dissolve tablets in 4 ounces of water before taking
  • Adults and children
    12 years and over
    2 tablets every 4 hours do not exceed 8 tablets in 24 hours
    60 years and older2 tablets every 4 hours do not exceed 4 tablets in 24 hours

Other Information



  • each tablet contains: sodium 540 mg
  • protect from 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



WESTERN
FAMILY®

Antacid & Pain Relief Medicine
Effervescent
PAIN RELIEF

Aspirin (NSAID) / Pain Reliever, Citric Acid /
Antacid, Sodium Bicarbonate / Antacid

FAST RELIEF OF:

Acid Indigestion, Upset Stomach, Heartburn
With Headache, Body Aches & Pains

36
TABLETS

COMPARE TO ALKA-SELTZER®active ingredients*


* Please review the disclaimer below.