Label: LEADER EXTRA STRENGTH EFFERVESCENT ANTACID AND PAIN RELIEVER- aspirin, citric acid, sodium bicarbonate tablet, effervescent
- NDC Code(s): 70000-0574-1
- Packager: Cardinal Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 14, 2024
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- Official Label (Printer Friendly)
- Active ingredients
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Purpose
(in each effervescent tablet)
Anhydrous citric acid 1000 mg..............................................................Antacid
Aspirin 500 mg (NSAID)*......................................................................Pain Reliever
Sodium bicarbonate (heat-treated) 1985 mg........................................Antacid
*Nonsteroidal anti-inflammatory drug
- Uses
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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
- Ask a doctor before use if
- Ask a doctor or pharmacist before use if you are
- When using this product
-
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
- Keep out of reach of children.
- OVERDOSAGE
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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
- Inactive ingredients
- Questions or comments?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LEADER EXTRA STRENGTH EFFERVESCENT ANTACID AND PAIN RELIEVER
aspirin, citric acid, sodium bicarbonate tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0574 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 1985 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 500 mg ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 1000 mg Inactive Ingredients Ingredient Name Strength LEMON (UNII: 24RS0A988O) Product Characteristics Color white Score no score Shape ROUND Size 25mm Flavor Imprint Code PXS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0574-1 18 in 1 CARTON 06/25/2021 1 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 06/25/2021 Labeler - Cardinal Health (063997360)