EFFERVESCENT PAIN RELIEF- aspirin, citric acid monohydrate, and sodium bicarbonate tablet, effervescent

Effervescent Pain Relief by

Drug Labeling and Warnings

Effervescent Pain Relief by is a Otc medication manufactured, distributed, or labeled by Western Family Foods, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each effervescent tablet)	Purpose
* nonsteroidal anti-inflammatory drug
Aspirin (NSAID)* 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

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

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

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.

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 children12 years and over: 2 tablets every 4 hours do not exceed 8 tablets in 24 hours
• 60 years and older: 2 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

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

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*

INGREDIENTS AND APPEARANCE

EFFERVESCENT PAIN RELIEF 
aspirin, citric acid monohydrate, and sodium bicarbonate tablet, effervescent

Product 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)