CERTI-CET PLUS  EXTRA STRENGTH- acetaminophen tablet 
Certified Safety Manufacturing

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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CERTI-CET PLUS™
Extra Strength

Drug Facts

Active Ingredients (each tablet)

Acetaminophen 500 mg

Purpose

Analgesic/Antipyretic

Uses

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 everyday 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 user has liver disease.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop use and ask doctor if

  • symptoms do not improve
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • a rare sensitivity reaction occurs.

If pregnant or breast-feeding

  • ask a health professional before use.

Keep out of the reach of children

  • In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not exceed recommended dosage.

Directions

  • Adults and children 12 years of age and older
Take 2 tablets every 4 to 6 hours as needed.
Do not take more than 8 tablets in 24 hours.
  • Children under 12 years of age
Do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

Other information

Inactive ingredients

May contain providone and sodium starch glycolates.

Questions?

Call 1-800-854-7474

PRINCIPAL DISPLAY PANEL - 500 mg Tablet Pouch Box

Tamper evident
packaging:
Do not use if
open or torn.

This package for
households
without children

See New Warnings
Information

Compare to Tylenol®

CERTI-CET
PLUS

EXTRA STRENGTH
500 mg Acetaminophen

PRINCIPAL DISPLAY PANEL - 500 mg Tablet Pouch Box
CERTI-CET PLUS   EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48083-310
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen500 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
STARCH, CORN (UNII: O8232NY3SJ)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize12mm
FlavorImprint Code AZ;235
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48083-310-2725 in 1 BOX12/29/2017
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:48083-310-3050 in 1 BOX12/29/2017
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:48083-310-33125 in 1 BOX12/29/2017
32 in 1 POUCH; Type 0: Not a Combination Product
4NDC:48083-310-36250 in 1 BOX12/29/2017
42 in 1 POUCH; Type 0: Not a Combination Product
5NDC:48083-310-39500 in 1 BOX12/29/2017
52 in 1 POUCH; Type 0: Not a Combination Product
6NDC:48083-310-3150 in 1 BOX12/29/2017
62 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/29/2017
Labeler - Certified Safety Manufacturing (788460483)

Revised: 4/2018
Document Id: 161cea83-fb45-4276-822a-14d2d2fa71a1
Set id: dcca9568-8eb5-4d70-a312-e6e1082f9972
Version: 1
Effective Time: 20180412
 
Certified Safety Manufacturing