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NDC 36800-0369-78 Topcare 8 Hour Pain Relief 650 mg/1 Details
Topcare 8 Hour Pain Relief 650 mg/1
Topcare 8 Hour Pain Relief is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. 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: 36800-0369-78Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
Product Information
| NDC | 36800-0369 |
|---|---|
| Product ID | 36800-369_78e4d3ce-8928-40c9-af82-1530f32e0a7c |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Topcare 8 Hour Pain Relief |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 650 |
| Active Ingredient Units | mg/1 |
| Substance Name | ACETAMINOPHEN |
| Labeler Name | Topco Associates LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA075077 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 36800-0369-78 (36800036978)
| NDC Package Code | 36800-369-78 |
|---|---|
| Billing NDC | 36800036978 |
| Package | 1 BOTTLE in 1 CARTON (36800-369-78) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE |
| Marketing Start Date | 2017-04-05 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 38abe710-3d8a-41b0-b057-38c5dfd53322 Details
Uses
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- •
- more than 6 caplets in 24 hours, which is the maximum daily amount
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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.
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- if you are allergic to acetaminophen or any of the inactive ingredients in this product
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 |
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Other information
Inactive ingredients
Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
| TOPCARE 8 HOUR PAIN RELIEF
acetaminophen tablet, film coated, extended release |
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| Labeler - Topco Associates LLC (006935977) |