Label: WALGREENS ANTACID PAIN RELIEF EXTRA STRENGTH- aspirin, citric acid, sodium bicarbonate tablet, effervescent

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated April 16, 2021

If you are a consumer or patient please visit this version.

  • 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 (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 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 doctore 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

    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.

  • OVERDOSAGE

    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?

    1-888-228-6937

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Walgreens Pain Extra Strength 36

  • INGREDIENTS AND APPEARANCE
    WALGREENS ANTACID PAIN RELIEF EXTRA STRENGTH 
    aspirin, citric acid, sodium bicarbonate tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0541
    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:0363-0541-3618 in 1 CARTON02/05/2021
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34302/05/2021
    Labeler - Walgreens (008965063)