PLUS PHARMA PAIN RELIEVER,FEVER REDUCER- acetaminophen tablet

Plus Pharma by

Drug Labeling and Warnings

Plus Pharma by is a Otc medication manufactured, distributed, or labeled by Gemini Pharmaceuticals, Inc. dba Plus Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Acetaminophen 325 mg

PURPOSE

Purposes

Pain reliever/fever reducer

INDICATIONS & USAGE

Uses

• temporarily relieves minor aches and pains due to:
• headache
• muscular aches
• backache
• minor pain of arthritis
• common cold
• toothache
• premenstrual and menstrual cramps
• temporarily reduces fever.

WARNINGS

Warnings

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

• adult takes more than 4,000 mg of acetaminophen in 24 hours
• 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
• 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.

DOSAGE & ADMINISTRATION

Directions

• do not take more than directed (see overdose warning)

• adults and children 12 years and over:
  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
• children 6 years to under 12 years:
  • take 1 tablet every 4 to 6 hours, while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctor
• children under 6 years: ask a doctor

STORAGE AND HANDLING

Other information

• store at room temperature in a dry place

INACTIVE INGREDIENT

Inactive ingredients

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

PlusPHARMA®

NDC: 51645-703-01

See New Warnings Information & Directions

Regular Strength

ACETAMINOPHEN 325 mg

PAIN RELIEVER FEVER REDUCER

CONTAINS NO ASPIRIN

Contains no ingredient from a gluten-containing grain (wheat, barley, or rye).

*Compare to the Active Ingredient in Regular Strength Tylenol®

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

100 TABLETS 325 mg each

INGREDIENTS AND APPEARANCE

PLUS PHARMA  PAIN RELIEVER,FEVER REDUCER
acetaminophen tablet

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

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

Inactive Ingredients
Ingredient Name	Strength
POVIDONE (UNII: FZ989GH94E)
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51645-703-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2006
2	NDC: 51645-703-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2006
3	NDC: 51645-703-05	50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2006	11/30/2017

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

Labeler - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)

Establishment
Name	Address	ID/FEI	Business Operations
Gemini Pharmaceuticals, Inc. dba Plus Pharma		055942270	manufacture(51645-703)