QUALITY CHOICE EXTRA STRENGTH EFFERVESCENT ANTACID AND PAIN RELIEF- aspirin, anhydrous citric acid, sodium bicarbonate tablet, effervescent 
Chain Drug Marketing Association

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Quality Choice Effervescent Antacid and Pain Relief Extra Strength

Active ingredients

(in each effervescent tablet)

Anhydrous citric acid 1000mg

Aspirin 500 mg (NSAID)*

Sodium bicarbonate (heat-treated) 1985 mg

*Nonsteroidal anti-inflammatory drug

Purpose

Anhydrous citric acid 1000mg………………………………………..........Antacid

Aspirin 500 mg (NSAID)*………………………………………..........…...Pain Reliever

Sodium bicarbonate (heat-treated) 1985 mg……………………...…….Antacid

*Nonsteroidal anti-inflammatory drug

Uses

Uses for the temporary relief of

■ 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

■ headache, body aches and pain alone

Warnings

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 an 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 (anti-coagulant) 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

Do not use

■ if you are allergic to aspirin or any other pain reliever/fever reducer

■ if you have ever had an allergic reaction to this product or any of its ingredients

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.

■ taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis

When using this product

​When using this product 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 2 weeks, except under the advice and supervision of a physician.

Stop use and ask a doctor if

Stop use and ask a doctor if ■ 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

If pregnant 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.

Keep out of reach of children.

In case of overdose, 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

Children under 12 years: consult a doctor

Other information

■ each tablet contains: sodium 575 mg

■ store at room temperature (59º-86ºF)

Inactive Ingredients:

flavor

Questions or comments?

1-800-935-2361

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Quality Choice PXS 24

QUALITY CHOICE EXTRA STRENGTH EFFERVESCENT ANTACID AND PAIN RELIEF 
aspirin, anhydrous citric acid, sodium bicarbonate tablet, effervescent
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-569
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID1000 mg
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE1985 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN500 mg
Inactive Ingredients
Ingredient NameStrength
LEMON (UNII: 24RS0A988O)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize25mm
FlavorImprint Code PXS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-569-2412 in 1 CARTON11/04/2020
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34311/04/2020
Labeler - Chain Drug Marketing Association (011920774)

Revised: 4/2021
Document Id: c0a988b7-c67d-deb6-e053-2995a90a0214
Set id: 9f7d0c96-a561-a8a0-e053-2995a90a250b
Version: 2
Effective Time: 20210423
 
Chain Drug Marketing Association