OTC Medication Information: CVS Health Antacid and Pain Reliever

CVS HEALTH ANTACID AND PAIN RELIEVER- aspirin, sodium bicarbonate and anhydrous citric acid tablet, effervescent
CVS Pharmacy

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.

Purpose

Aspirin 325 mg (NSAID)*. . . . . . . . . . . . . . . . . . . . . .Pain reliever

Citric acid 1000 mg . . . . . . . . . . . . . . . . . . . . . .. . . . Antacid

Sodium bicarbonate (heat-treated) 1916 mg . . . . . . Antacid

*Nonsteroidal anti-inflammatory drug

Active ingredients

(in each efferevescent tablet)

Aspirin 325 mg (NSAID)*

Citric acid 1000 mg

Sodium bicarbonate (heat-treated) 1916 mg

*Nonsteroidal anti-inflammatory drug

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

■ pain alone (headaches or body aches and pains)

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 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 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 have ever had an allergic reaction to any other pain reliever/fever reducer

■ if you are allergic to aspirin ■ if overly full from food or drink. Ask a doctor if severe stomach pain occurs after taking this product.

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 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

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 10 days

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 breastfeeding,

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.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

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

Other information

each tablet contains: sodium 524 mg

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

Inactive ingredients

■ none

Questions or comments?

1-888-228-6937

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Pain 36ct
(click image for full-size original)

CVS HEALTH ANTACID AND PAIN RELIEVER
aspirin, citric acid, sodium bicarbonate tablet, effervescent
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-421
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 325 mg
SODIUM BICARBONATE (BICARBONATE ION) SODIUM BICARBONATE 1916 mg
ANHYDROUS CITRIC ACID (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID 1000 mg
Product Characteristics
Color white Score no score
Shape ROUND Size 25mm
Flavor Imprint Code L421
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69842-421-36 18 POUCH in 1 CARTON contains a POUCH
1 2 TABLET, EFFERVESCENT in 1 POUCH This package is contained within the CARTON (69842-421-36)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 12/01/2006
Labeler — CVS Pharmacy (062312574)

Revised: 10/2019 CVS Pharmacy

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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