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NDC 63868-0679-50 8 Hour Pain Relief 650 mg/1 Details
8 Hour Pain Relief 650 mg/1
8 Hour Pain Relief is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by CHAIN DRUG MARKETING ASSOCIATION INC. 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: 63868-0679-50Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
Product Information
| NDC | 63868-0679 |
|---|---|
| Product ID | 63868-679_ae065210-9198-f773-e053-2995a90afa66 |
| 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 | 8 Hour Pain Relief |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 650 |
| Active Ingredient Units | mg/1 |
| Substance Name | ACETAMINOPHEN |
| Labeler Name | CHAIN DRUG MARKETING ASSOCIATION INC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA211544 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63868-0679-50 (63868067950)
| NDC Package Code | 63868-679-50 |
|---|---|
| Billing NDC | 63868067950 |
| Package | 1 BOTTLE, PLASTIC in 1 CARTON (63868-679-50) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2020-08-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 1da0bd23-9f26-4913-9ebf-1fd8b0fb3bd3 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
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert
Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
- 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 are allergic to acetaminophen or any of the inactive ingredients in this product
Directions
- do not take more than directed (see overdose warning)
| adults and children 12 years and over |
|
| children under 12 years |
|
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL
NDC 63868-679-50
Quality Choice®
†Compare to the active ingredient in Tylenol® 8HR
8 Hour Pain Relief
Acetaminophen Extended Release Tablets, 650 mg
Pain Reliever / Fever Reducer
For up to 8 Hour Relief of Minor Muscle Aches and Pain
Actual Size
50 CAPLETS** - 650 MG EACH (**Capsule-Shaped Bi-Layer Tablets)
INGREDIENTS AND APPEARANCE
| 8 HOUR PAIN RELIEF
acetaminophen tablet, extended release |
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| Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774) |