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NDC 61919-0271-60 EXTRA STRENGTH PAIN RELIEF 500 mg/1 Details
EXTRA STRENGTH PAIN RELIEF 500 mg/1
EXTRA STRENGTH PAIN RELIEF is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Direct_Rx. 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: 61919-0271-60Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
Product Information
| NDC | 61919-0271 |
|---|---|
| Product ID | 61919-271_b855548f-ebc0-6dc8-e053-2995a90a6632 |
| 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 | EXTRA STRENGTH PAIN RELIEF |
| 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 | Direct_Rx |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part343 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 61919-0271-60 (61919027160)
| NDC Package Code | 61919-271-60 |
|---|---|
| Billing NDC | 61919027160 |
| Package | 60 TABLET in 1 BOTTLE (61919-271-60) |
| Marketing Start Date | 2019-07-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 8ee83e3a-e8e2-1709-e053-2995a90a7cdd Details
SPL UNCLASSIFIED SECTION
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take
more than 8 tablets 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
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.
Ask a doctor before use if you have
liver disease.
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin.
Stop use and ask a doctor if
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
new symptom occur
redness or swelling is present
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Overdose Warning:
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Keep out of reach of children.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| EXTRA STRENGTH PAIN RELIEF
acetaminophen tablet |
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| Labeler - Direct_Rx (079254320) |
| Registrant - Direct_Rx (079254320) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Direct_Rx | 079254320 | repack(61919-271) | |