ACETAMINOPHEN PAIN RELIEF

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
NDC Code: 49999-099

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.

Acetaminophen Tablet

*Compared to the active ingredient in Extra-Strength Tylenol® Tablets

Drug Facts

ACTIVE INGREDIENT

(in each tablet)

Acetaminophen 500 mg

PURPOSES

Pain Reliever/Fever Reducer

Keep Out of Reach of Children

Keep out of reach of children

USES
  • temporarily relieves minor aches and pains
  • temporarily relieves reduces fever

WARNINGS

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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.

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.

OVERDOSAGE

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. 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 1-2 tablets every 4-6 hours, as needed. Do not take more than 8 tablets in 24 hours.
Children under 12 yearsDo not use.

OTHER INFORMATION

TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.

  • store at 20°-25°C (68°-77°F)
  • for institutional use only

INACTIVE INGREDIETNS:

povidone, sodium starch glycolate, starch, stearic acid. May also contain: crospovidone, methylparaben and propylparaben

Distributor Information:

*This product is not manufactured or distributed by the owner of the registered trademark TYLENOL®.

Distributed by: GERI-CARE PHARMACEUTICALS CORP. 1650 63rd St., Brooklyn, New York 11204

This Product was Repackaged By Sandhills Packaging For:

Keltman Pharmaceuticals Inc.
1 Lakeland Square, Suite A
Flowood, MS 39232
United States

Image of Label

ACETAMINOPHEN  PAIN RELIEF
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49999-099(NDC:57896-201)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE 
STARCH, CORN 
STEARIC ACID 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorImprint CodeM2A4;57344
Contains    
Packaging
#Item CodePackage Description
1NDC:49999-099-2020 TABLET (TABLET) in 1 BOTTLE, PLASTIC
2NDC:49999-099-3030 TABLET (TABLET) in 1 BOTTLE, PLASTIC
3NDC:49999-099-6060 TABLET (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34302/02/2012
Labeler - Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC (831276758)
Establishment
NameAddressID/FEIOperations
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC831276758repack, relabel

Revised: 02/2012
 
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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