ACETAMINOPHEN ES- pharbetol tablet 
Contract Pharmacy Services-PA

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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Drug Facts

"These highlights do not include all the information needed to use" "see full prescribing information for" "Initial U.S. Approval"

Active ingredient (in each tablet)

Acetaminophen 500mg

Purpose

Pain reliever/fever reducer

Uses

Temporarily relieves minor aches and pains due to:

Temporarily 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
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product


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 and ask doctor before use 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 pregant or breast-feeding, ask doctor before use.

Keep out of reach of children.

Directions

  • do not take more than directed (see overdose warning).
  • Adult and Children 12 years and over: take 2 tablets, every 4 to 6 hours while symptoms last. Do not take more than 8 tablets in 24 hours. Do not take for more than 10 days unless directed by a doctor.
  • Children under 12 years: do not use adult extra strength product in children under 12 years of age; this will provide more than recommended dose (overdose) and may cause liver damage.

Overdose warning:

Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away.

Inactive ingredients

Povidone, Pregelatinized corn starch, sodium starch glycolate, stearic acid.

Questions?

Adverse drug event call: (866) 562-2756

apa

ACETAMINOPHEN ES 
pharbetol tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67046-028(NDC:16103-376)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30 (UNII: U725QWY32X)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize12mm
FlavorImprint Code PH044
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67046-028-3030 in 1 BLISTER PACK; Type 0: Not a Combination Product01/10/2006
2NDC:67046-028-6060 in 1 BLISTER PACK; Type 0: Not a Combination Product01/10/2006
3NDC:67046-028-6260 in 1 BLISTER PACK; Type 0: Not a Combination Product01/10/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/10/2006
Labeler - Contract Pharmacy Services-PA (945429777)
Establishment
NameAddressID/FEIBusiness Operations
Coupler Enterprises Inc.945429777repack(67046-028)

Revised: 4/2018
Document Id: 6a70eacf-aecb-73f5-e053-2a91aa0a5daf
Set id: 6a70eac1-9947-80a8-e053-2991aa0abfde
Version: 1
Effective Time: 20180422
 
Contract Pharmacy Services-PA