OTC Medication Information: Plus Pharma Pain Reliever,Fever Reducer

PLUS PHARMA PAIN RELIEVER,FEVER REDUCER- acetaminophen tablet
Unit Dose Services

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.

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.

ACETAMINOPHEN 325MG TAB 24EA

Label Image
(click image for full-size original)
PLUS PHARMA PAIN RELIEVER,FEVER REDUCER
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50436-0703(NDC:51645-703)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONES
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A CORN
STEARIC ACID
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 Multilevel Packaging
1 NDC:50436-0703-1 24 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 03/27/2006
Labeler — Unit Dose Services (831995316)
Registrant — Unit Dose Services (831995316)
Establishment
Name Address ID/FEI Operations
Unit Dose Services 831995316 REPACK (50436-0703), RELABEL (50436-0703)

Revised: 07/2016 Unit Dose Services

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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