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NDC 70000-0373-04 leader Acetaminophen 500 mg/1 Details
leader Acetaminophen 500 mg/1
leader Acetaminophen is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health 110, LLC. dba Leader. The primary component is ACETAMINOPHEN.
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 70000-0373-04Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
Product Information
| NDC | 70000-0373 |
|---|---|
| Product ID | 70000-0373_7926415e-e0c7-4376-b60c-76c0fb0e1e62 |
| Associated GPIs | 64200010000315 |
| GCN Sequence Number | 004490 |
| GCN Sequence Number Description | acetaminophen TABLET 500 MG ORAL |
| HIC3 | H3E |
| HIC3 Description | ANALGESIC/ANTIPYRETICS,NON-SALICYLATE |
| GCN | 16965 |
| HICL Sequence Number | 001866 |
| HICL Sequence Number Description | ACETAMINOPHEN |
| Brand/Generic | Generic |
| Proprietary Name | leader Acetaminophen |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/1 |
| Substance Name | ACETAMINOPHEN |
| Labeler Name | Cardinal Health 110, LLC. dba Leader |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part343 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 70000-0373-04 (70000037304)
| NDC Package Code | 70000-0373-4 |
|---|---|
| Billing NDC | 70000037304 |
| Package | 1 BOTTLE in 1 CARTON (70000-0373-4) / 225 TABLET in 1 BOTTLE |
| Marketing Start Date | 2018-08-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 36bdcac9-eed4-40f9-a6f2-4c1e773a6b50 Details
Uses
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- •
- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- •
- if you have ever had an allergic reaction to this product or any of its ingredients
Directions
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- do not take more than directed (see overdose warning)
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adults and children 12 years and over |
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children under 12 years |
ask a doctor |
Inactive ingredients
Principal Display Panel
INGREDIENTS AND APPEARANCE
| LEADER ACETAMINOPHEN
acetaminophen tablet |
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| Labeler - Cardinal Health 110, LLC. dba Leader (063997360) |