ACETAMINOPHEN- acetaminophen tablet 
Advance Pharmaceutical Inc.

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 325 mg

Active Ingredient

(in each tablet)

Acetaminophen 325 mg

Purpose

Pain Reliever / Fever Reducer

Uses

temporarily reduces fever and relieves minor aches and pains caused by

Warnings

Liver warning: this product contains acetaminophen. Severe liver damage may occur if

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.

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

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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 1-2 tablets every 4 hours or 2-3 tablets every 6 hours while symptoms last, not more than 12 tablets in 24 hours
children 6 to 11 years 1 tablet every 4 hours while symptoms last, not more than 5 tablets in 24 hours
children under 6 yearsask a doctor

Other Information

For Bulk package: This is a bulk package, dispense contents with a child-resistant closure in a tight, light resistant container as defined in the USP.

Inactive Ingredients

polyvinylpyrrolidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

Questions or Comments

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1d2e4055-figure-01

1d2e4055-figure-02

1d2e4055-figure-03

NDC: 17714-012-01 – 100 COUNT

NDC: 17714-012-10 – 1000 COUNT

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17714-012
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize8mm
FlavorImprint Code AP;012
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17714-012-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/05/1989
2NDC:17714-012-101000 in 1 BOTTLE; Type 0: Not a Combination Product02/05/1989
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34302/05/1989
Labeler - Advance Pharmaceutical Inc. (078301063)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIBusiness Operations
Advance Pharmaceutical Inc.078301063manufacture(17714-012)

Revised: 12/2017
Document Id: 60f41580-e068-faad-e053-2a91aa0a9076
Set id: 3793a17e-13bf-4d27-b8fa-6753b760f820
Version: 3
Effective Time: 20171222
 
Advance Pharmaceutical Inc.