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NDC 70000-0574-01 Leader Extra Strength Effervescent Antacid and Pain Reliever 1000; 500; 1985 mg/1; mg/1; mg/1 Details
Leader Extra Strength Effervescent Antacid and Pain Reliever 1000; 500; 1985 mg/1; mg/1; mg/1
Leader Extra Strength Effervescent Antacid and Pain Reliever is a ORAL TABLET, EFFERVESCENT in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health. The primary component is ANHYDROUS CITRIC ACID; ASPIRIN; SODIUM BICARBONATE.
Product Information
NDC | 70000-0574 |
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Product ID | 70000-0574_c5d7bf5f-3e5a-52f2-e053-2a95a90a4a00 |
Associated GPIs | 64109902110830 |
GCN Sequence Number | 073553 |
GCN Sequence Number Description | aspirin/sod bicarb/citric acid TABLET EFF 500-1985MG ORAL |
HIC3 | H3D |
HIC3 Description | ANALGESIC/ANTIPYRETICS, SALICYLATES |
GCN | 37974 |
HICL Sequence Number | 001801 |
HICL Sequence Number Description | ASPIRIN/SODIUM BICARBONATE/CITRIC ACID |
Brand/Generic | Generic |
Proprietary Name | Leader Extra Strength Effervescent Antacid and Pain Reliever |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Aspirin, Citric Acid, Sodium Bicarbonate |
Product Type | HUMAN OTC DRUG |
Dosage Form | TABLET, EFFERVESCENT |
Route | ORAL |
Active Ingredient Strength | 1000; 500; 1985 |
Active Ingredient Units | mg/1; mg/1; mg/1 |
Substance Name | ANHYDROUS CITRIC ACID; ASPIRIN; SODIUM BICARBONATE |
Labeler Name | Cardinal Health |
Pharmaceutical Class | Acidifying Activity [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Cyclooxygenase Inhibitors [MoA], Decreased Coagulation Factor Activity [PE], Decreased Platel |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part343 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 70000-0574-01 (70000057401)
NDC Package Code | 70000-0574-1 |
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Billing NDC | 70000057401 |
Package | 18 POUCH in 1 CARTON (70000-0574-1) / 2 TABLET, EFFERVESCENT in 1 POUCH |
Marketing Start Date | 2021-06-25 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c5d7bf5f-3e59-52f2-e053-2a95a90a4a00 Details
Active ingredients
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
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
SPL UNCLASSIFIED SECTION
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
INGREDIENTS AND APPEARANCE
LEADER EXTRA STRENGTH EFFERVESCENT ANTACID AND PAIN RELIEVER
aspirin, citric acid, sodium bicarbonate tablet, effervescent |
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Labeler - Cardinal Health (063997360) |