DailyMed - PLUSPHARMA EXTRA STRENGTH PAIN RELIEVER,FEVER REDUCER 500 MG- acetaminophen tablet

Contains inactivated NDC Code(s)
NDC Code(s): 50090-5548-1, 50090-5548-2, 50090-5548-4
Packager: A-S Medication Solutions
This is a repackaged label.
Source NDC Code(s): 51645-706

Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 2, 2021

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SPL UNCLASSIFIED SECTION
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING - Drug Facts

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Drug Facts
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ACTIVE INGREDIENT
Active ingredient (in each tablet) Acetaminophen 500 mg

Active ingredient (in each tablet)

Acetaminophen 500 mg

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PURPOSE
Purposes - Pain reliever/fever reducer

Purposes

Pain reliever/fever reducer

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INDICATIONS & USAGE
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 ...
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
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WARNINGS
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 ...
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.
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
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 symptoms 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.

Keep out of reach of children.

Overdose Warning: In 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.

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DOSAGE & ADMINISTRATION
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 - do not take more than 6 tablets in 24 ...
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
- 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
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STORAGE AND HANDLING
Other information - store at room temperature in a dry place
Other information
- store at room temperature in a dry place
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INACTIVE INGREDIENT
Inactive ingredients Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Inactive ingredients Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

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QUESTIONS
Questions? If you have any questions or comments, or to report an adverse event, please contact - (800) 795-9775.

Questions? If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.
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SPL UNCLASSIFIED SECTION
Distributed By: Plus Pharma, Commack, NY 11725 - Manufactured in a GMP facility in the USA

Distributed By: Plus Pharma, Commack, NY 11725

Manufactured in a GMP facility in the USA
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HOW SUPPLIED
Product: 50090-5548 - NDC: 50090-5548-4 24 TABLET in a BOTTLE - NDC: 50090-5548-1 30 TABLET in a BOTTLE - NDC: 50090-5548-2 100 TABLET in a BOTTLE, PLASTIC

Product: 50090-5548

NDC: 50090-5548-4 24 TABLET in a BOTTLE

NDC: 50090-5548-1 30 TABLET in a BOTTLE

NDC: 50090-5548-2 100 TABLET in a BOTTLE, PLASTIC
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PLUSPHARMA EXTRA STRENGTH PAIN RELIEVER,FEVER REDUCER 500 MG (ACETAMINOPHEN) TABLET (What is this?)

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INGREDIENTS AND APPEARANCE

Product Information

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-5548) , REPACK(50090-5548)

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	RxCUI	RxNorm NAME	RxTTY
1	198440	acetaminophen 500 MG Oral Tablet	PSN
2	198440	acetaminophen 500 MG Oral Tablet	SCD
3	198440	APAP 500 MG Oral Tablet	SY

	NDC
1	50090-5548-1 (inactivated)
2	50090-5548-2 (inactivated)
3	50090-5548-4 (inactivated)

Label: PLUSPHARMA EXTRA STRENGTH PAIN RELIEVER,FEVER REDUCER 500 MG- acetaminophen tablet

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Label: PLUSPHARMA EXTRA STRENGTH PAIN RELIEVER,FEVER REDUCER 500 MG- acetaminophen tablet

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PLUSPHARMA EXTRA STRENGTH PAIN RELIEVER,FEVER REDUCER 500 MG- acetaminophen tablet

Number of versions: 1

PLUSPHARMA EXTRA STRENGTH PAIN RELIEVER,FEVER REDUCER 500 MG- acetaminophen tablet

PLUSPHARMA EXTRA STRENGTH PAIN RELIEVER,FEVER REDUCER 500 MG- acetaminophen tablet

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PLUSPHARMA EXTRA STRENGTH PAIN RELIEVER,FEVER REDUCER 500 MG- acetaminophen tablet

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.