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NDC 41163-0669-50 Acetaminophen 650 mg/1 Details
Acetaminophen 650 mg/1
Acetaminophen is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by EQUALINE (SuperValu). 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: 41163-0669-50Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
Product Information
| NDC | 41163-0669 |
|---|---|
| Product ID | 41163-669_328d078e-240a-40f3-b23a-787bd72d2930 |
| 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 | Acetaminophen |
| Proprietary Name Suffix | Extended Release |
| Non-Proprietary Name | Acetaminophen |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 650 |
| Active Ingredient Units | mg/1 |
| Substance Name | ACETAMINOPHEN |
| Labeler Name | EQUALINE (SuperValu) |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA207035 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 41163-0669-50 (41163066950)
| NDC Package Code | 41163-669-50 |
|---|---|
| Billing NDC | 41163066950 |
| Package | 1 BOTTLE, PLASTIC in 1 BOX (41163-669-50) / 50 TABLET in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2019-09-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c1d176c6-3434-4b6a-9e86-d3f28132dfaf 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 ever 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 a 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
Inactive ingredients
Principal Display Panel
compare Tylenol® 8HR Arthritis Pain active ingredient†
extended-release
arthritis pain reliever
acetaminophen 650 mg
pain reliever/fever reducer
for the temporary relief of minor arthritis pain
caplets* (*capsule-shaped bi-layer tablets)
†This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® 8 HR Arthritis Pain.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY: SUPERVALU INC., EDEN PRAIRIE, MN 55344 USA
INGREDIENTS AND APPEARANCE
| ACETAMINOPHEN
EXTENDED RELEASE
acetaminophen tablet |
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| Labeler - EQUALINE (SuperValu) (006961411) |