NDC | 55312-469-80 |
Set ID | 275d4196-52da-4cd1-a90c-ced7ea02526e |
Category | HUMAN OTC DRUG LABEL |
Packager | Western Family Foods, Inc. |
Generic Name | |
Product Class | Anti-coagulant |
Product Number | |
Application Number | PART343 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
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
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.
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
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
- Directions
- Other Information
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 36 Tablet Carton
WESTERN
FAMILY®Antacid & Pain Relief Medicine
Effervescent
PAIN RELIEFAspirin (NSAID) / Pain Reliever, Citric Acid /
Antacid, Sodium Bicarbonate / AntacidFAST RELIEF OF:
Acid Indigestion, Upset Stomach, Heartburn
With Headache, Body Aches & Pains36
TABLETSCOMPARE TO ALKA-SELTZER®active ingredients*
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INGREDIENTS AND APPEARANCE
EFFERVESCENT PAIN RELIEF
aspirin, citric acid monohydrate, and sodium bicarbonate tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55312-469 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin 325 mg Citric Acid Monohydrate (UNII: 2968PHW8QP) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid 1000 mg Sodium Bicarbonate (UNII: 8MDF5V39QO) (Bicarbonate Ion - UNII:HN1ZRA3Q20) Sodium Bicarbonate 1916 mg Product Characteristics Color WHITE Score 2 pieces Shape ROUND Size 25mm Flavor Imprint Code C11 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55312-469-80 18 in 1 CARTON 1 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part343 01/28/2008 Labeler - Western Family Foods, Inc. (192166072)