ACETAMINOPHEN- acetaminophen tablet, coated 
Central Texas Community Health Centers

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 Tablets

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

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

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 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 in children 12 years and over
  • 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

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 this adult product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other information

Inactive ingredients

crospovidone, methylparaben, povidone, pregelatinized starch, propylparaben, sodium starch glycolate, stearic acid

Distributed By McKesson
One Post Street, San Francisco, CA 94104

PRINCIPAL DISPLAY PANEL - 325 MG Tablet Bottle Label

CommUnityCare Federally Qualified Health Centers

ACETAMINOPHEN
325MG #30 TABS

Date:

Name:
Dr.

TAKE AS DIRECTED.

123456

1/1/01

ACETAMINOPHEN 325mg #30 NDC 76413-301-30

Batch: 123456
Lot: 123456
Exp: 1/1/01
SUNMARK

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

Principal Display Panel - 325 MG Tablet Bottle Label
ACETAMINOPHEN 
acetaminophen tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76413-301(NDC:49348-973)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONES (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code M2A3;57344
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76413-301-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/13/2012
Labeler - Central Texas Community Health Centers (079674019)
Establishment
NameAddressID/FEIBusiness Operations
Central Texas Community Health Centers079674019REPACK(76413-301) , RELABEL(76413-301)

Revised: 3/2016
Document Id: a368de95-b5b7-4aa2-bde4-ccca6efb42de
Set id: ba4b33b3-e071-4b03-88a0-89dc85f61625
Version: 1
Effective Time: 20160309
 
Central Texas Community Health Centers