PLUS PHARMA PAIN RELIEVER,FEVER REDUCER- acetaminophen tablet
Proficient Rx LP

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.

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Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purposes

Pain reliever/fever reducer

Uses

for the temporary relief of 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

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

•: adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
•: child takes more than 5 doses in 24 hours
•: taken with other drugs containing acetaminophen
•: adult has 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 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

Ask a doctor before use if the user has

liver disease.

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

•: Pain gets worse or lasts more than 10 days in adults and children
•: Pain gets worse or lasts more than 5 days in children under 12 years
•: 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:

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. (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

AGE	DOSE
Adults and Children 12 years and over	• Take 2 tablets every 4 to 6 hours while symptoms last • Do not take more than 12 tablets in 24 hours
Children 6 - 11 years	• Take 1 tablet every 4 to 6 hours while symptoms last • Do not take more than 5 tablets in 24 hours
Children under 6 years	Do not use adult Regular Strength products in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

Other information

•: Do not use if imprinted Safety Seal under cap is broken or missing
•: Store at room temperature

Inactive ingredients

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.

Questions?

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

Principal Display Panel

See New Warnings Information

NDC 63187-528-30

PlusPHARMA

Repackaged and Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

Regular Strength

ACETAMINOPHEN

325 mg

PAIN RELIEVER FEVER REDUCER

CONTAINS NO ASPIRIN

Compare to the Active Ingredient in Regular Strength Tylenol®

*Plus Pharma is not affiliated with the owner of the registered trademark Tylenol®.

30 TABLETS 325 mg each

PLUS PHARMA PAIN RELIEVER,FEVER REDUCER
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-528(NDC:51645-703)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Ingredient Name	Strength
Inactive Ingredients
CROSPOVIDONE (UNII: 2S7830E561)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (round)	Score	no score
Shape	ROUND (flat faced beveled edge)	Size	10mm
Flavor		Imprint Code	GPI;A325
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63187-528-20	20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2018	12/31/2023
2	NDC:63187-528-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2018	12/31/2023
3	NDC:63187-528-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2018	12/31/2023
4	NDC:63187-528-90	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2018	12/31/2023
5	NDC:63187-528-00	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2018	12/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	03/27/2006	12/31/2023

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	REPACK(63187-528) , RELABEL(63187-528)

Revised: 10/2022

Document Id: 8f79d0d6-4870-46bc-831c-d6bffbffb840

Set id: dfa7d1e3-74b2-4f55-a38f-1dd5f0cdca53

Version: 5

Effective Time: 20221001

Proficient Rx LP