Storage and handling
Other information store at room temperature in a dry place
PlusPharma Extra Strength
- Manufacturer
- A-S Medication Solutions
- Effective date
- 2021-09-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-05-31 23:42:24
Label at a glance#
ProductPlusPharma Extra Strength PAIN RELIEVER,FEVER REDUCER 500 mg
Active ingredientACETAMINOPHEN
Label structure12 sections
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each caplet)
Acetaminophen 500 mg
OTC - PURPOSE SECTION
Purposes
Pain reliever/fever reducer
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves minor aches and pains due to:
- headache
- muscular aches
- backache
- minor pain of arthritis
- the common cold
- toothache
- premenstrual and menstrual cramps
- temporarily reduces fever
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen. 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
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.
OTC - DO NOT USE SECTION
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
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have liver disease.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
OTC - STOP USE SECTION
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 symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Overdose warning: 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.
DOSAGE & ADMINISTRATION SECTION
Directions
- do not take more than directed (see overdose warning)
- adults and children 12 years and over:
- take 2 caplets every 6 hours while symptoms last
- do not take more than 6 caplets 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
STORAGE AND HANDLING SECTION
Other information
- store at room temperature in a dry place
INACTIVE INGREDIENT SECTION
Inactive ingredients Povidone, pregelatinized starch, sodium starch glycolate, stearic acid
OTC - QUESTIONS SECTION
Questions? If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.
SPL UNCLASSIFIED SECTION
Distributed By: Plus Pharma, Commack, NY 11725
Manufactured in a GMP facility in the USA
HOW SUPPLIED
Product: 50090-5537
NDC: 50090-5537-1 100 TABLET in a BOTTLE, PLASTIC
PLUSPHARMA EXTRA STRENGTH PAIN RELIEVER,FEVER REDUCER 500 MG (ACETAMINOPHEN) TABLET
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-5537-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-217a-0266-e053-dadaa90a7c1a | Acetaminophen 500 mg Caplet |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-5537-1 | PlusPharma Extra StrengthPAIN RELIEVER,FEVER REDUCER 500 mg | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-5537 | PLUSPHARMA EXTRA STRENGTH PAIN RELIEVER,FEVER REDUCER 500 MG (ACETAMINOPHEN) TABLET [A-S MEDICATION SOLUTIONS] | 4 | Legacy NDC, 1 package rows | 20210916_aea05de9-181e-4e09-841d-82d58c51b0c4.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-5537-1 | EA - Each | 50090-5537 | 17abf57c-bfee-4a6d-b298-37c57c961975 | 1 | 2022-03-09 |
Products#
Every source-derived product name is available through these pages.
- PlusPharma Extra Strength PAIN RELIEVER,FEVER REDUCER 500 mg
- ACETAMINOPHEN
- POVIDONE, UNSPECIFIED
- STARCH, CORN
- SODIUM STARCH GLYCOLATE TYPE A CORN
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50090-5537 | 50090-5537-1 |
| 51645-705 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 0cc51b5b-9d46-4b28-a8a1-077d4f2a9fa9 | aea05de9-181e-4e09-841d-82d58c51b0c4 | 2021-09-15 | Warnings | 0cc51b5b-9d46-4b28-a8a1-077d4f2a9fa9 aea05de9-181e-4e09-841d-82d58c51b0c4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.