ACETAMINOPHEN- acetaminophen tablet 
Richmond Pharmaceuticals, 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.

Overdose warning:Taking more than the recommended dose may cause liver damage. In case of overdose contact Poisom Control Center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs of symptoms.

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 over2 tablets every 4 to 6 hours while symptoms last, not more than 10 tablets in 24 hours. Do not use more than 10 days unless directed by doctor
children 6 to 11 years1 tablet every 4-6 hours while symptoms last, not more than 5 tablets in 24 hours. Do not use more than 5 days unless directed by doctor
children under 6 yearsask a doctor

Other Information

store at 15-30 °C (59-86 °F)

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

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

PRINCIPAL DISPLAY PANEL

NDC- 54738-548-01... 100 APAP 325MG TABS

IMG_4680

NDC- 54738-548-03... 1000 APAP 325MG TABS

NDC- 54738-548-50... 50 APAP 325MG TABS

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54738-548
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
ShapeROUNDSize10mm
FlavorImprint Code AP;012
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54738-548-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2015
2NDC:54738-548-031000 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2015
3NDC:54738-548-5050 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/01/2015
Labeler - Richmond Pharmaceuticals, Inc. (043569607)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIBusiness Operations
Advance Pharmaceutical Inc.078301063manufacture(54738-548)

Revised: 10/2017
Document Id: 5cc3aaa6-e192-a116-e053-2991aa0a1422
Set id: cda8e158-01ac-4c08-826e-4a0c7278e805
Version: 2
Effective Time: 20171030
 
Richmond Pharmaceuticals, Inc.