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NDC 63187-0293-10 PlusPharma Extra Strength 500 mg/1 Details
PlusPharma Extra Strength 500 mg/1
PlusPharma Extra Strength is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. 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: 63187-0293-10Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
Product Information
| NDC | 63187-0293 |
|---|---|
| Product ID | 63187-293_aa1ff859-2ff4-43e8-be4f-e0f4f369c20a |
| 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 | PlusPharma Extra Strength |
| Proprietary Name Suffix | PAIN RELIEVER,FEVER REDUCER 500 mg |
| 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 | Proficient Rx LP |
| 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 63187-0293-10 (63187029310)
| NDC Package Code | 63187-293-10 |
|---|---|
| Billing NDC | 63187029310 |
| Package | 10 TABLET in 1 BOTTLE, PLASTIC (63187-293-10) |
| Marketing Start Date | 2018-09-04 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 73bff948-3ecd-4700-994f-177c967f9164 Details
Uses
Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. Severe liver damage may occur if you take
- •
- more than 4,000 mg of acetaminophen in 24 hours
- •
- 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 non prescription). 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
Stop use and ask a doctor if
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- pain gets worse or lasts more than 10 days
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- fever gets worse or lasts more than 3 days
- •
- new symptoms occur
- •
- redness or swelling is present
These could be signs of a serious condition.
Keep out of reach of children.
Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
Do not take more than directed (see overdose warning)
Adults and children 12 years and over:
- •
- take 2 tablets every 6 hours while symptoms last
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- do not take more than 6 tablets in 24 hours unless directed by a doctor
- •
- do not take for more than 10 days unless directed by a doctor.
Children under 12 years: ask a doctor.
Other information
Questions?
Principal Display Panel
Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320
See New Warnings Information and Directions
Extra Strength
ACETAMINOPHEN 500 mg
PAIN RELIEVER FEVER REDUCER
CONTAINS NO ASPIRIN
Compare to the Active Ingredient in Extra Strength Tylenol®
This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®
30 TABLETS 500 mg each
INGREDIENTS AND APPEARANCE
| PLUSPHARMA EXTRA STRENGTH
PAIN RELIEVER,FEVER REDUCER 500 MG
acetaminophen tablet |
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| Labeler - Proficient Rx LP (079196022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Proficient Rx LP | 079196022 | REPACK(63187-293) , RELABEL(63187-293) | |