Acetaminophen 325 mg Tablets

Plus Pharma by

Drug Labeling and Warnings

Plus Pharma by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PLUS PHARMA PAIN RELIEVER,FEVER REDUCER- acetaminophen tablet 
REMEDYREPACK INC.

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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Acetaminophen 325 mg Tablets

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

AGEDOSE
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 yearsDo 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.

DRUG: Plus PharmaPain Reliever,Fever Reducer Pain Reliever,Fever Reducer

GENERIC: ACETAMINOPHEN

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-0444-0

NDC: 70518-0444-1

NDC: 70518-0444-2

NDC: 70518-0444-3

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 10 mm

IMPRINT: GPI;A325

PACKAGING: 20 in 1 BOTTLE, PLASTIC

PACKAGING: 100 in 1 BOTTLE PLASTIC

PACKAGING: 100 in 1 MANUFACTURERS PACKAGING

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • ACETAMINOPHEN 325mg in 1

INACTIVE INGREDIENT(S):

  • POVIDONE
  • SODIUM STARCH GLYCOLATE TYPE A CORN
  • STARCH, CORN
  • STEARIC ACID

Remedy_Label

MM2

MM3

MM4

PLUS PHARMA  PAIN RELIEVER,FEVER REDUCER
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70518-0444(NDC: 51645-703)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorwhite (round) Scoreno score
ShapeROUND (flat faced beveled edge) Size10mm
FlavorImprint Code GPI;A325
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70518-0444-020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/201704/06/2020
2NDC: 70518-0444-1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/02/201804/06/2020
3NDC: 70518-0444-2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/06/201804/06/2020
4NDC: 70518-0444-330 in 1 BLISTER PACK; Type 0: Not a Combination Product04/19/201804/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/05/201704/06/2020
Labeler - REMEDYREPACK INC. (829572556)

Revised: 4/2020
 
REMEDYREPACK INC.