APAP- 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 USP 500 mg

Active Ingredient

(in each caplet)

Acetaminophen 500 mg

Purpose

Pain Reliever / Fever Reducer

Uses

temporarily relieves minor aches and pains due to:

Warnings

Liver warning: this product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage may occur if you take

do not use

Ask a doctor before use if the you have liver disease

Ask a doctor or pharmacist before use if you are 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.

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other Information

Inactive Ingredients

hypromellose, polyethylene glyocol, polyvinylpyrrolidone, pregelatinized corn starch, sodium starch glycolate, stearic acid, TITANIUM DIOXIDE

Questions or Comments

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 54738-040-01 ..100 APAP 500mg tabs

IMG_4678

NDC: 54738-040-03 ..1000 APAP 500mg tabs

APAP 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54738-040
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)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize17mm
FlavorImprint Code AP;014
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54738-040-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2015
2NDC:54738-040-031000 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/01/2015
Labeler - Richmond Pharmaceuticals, Inc. (043569607)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIBusiness Operations
Advance Pharmaceutical Inc.078301063manufacture(54738-040)

Revised: 10/2017
Document Id: 5cc3aaa6-e19e-a116-e053-2991aa0a1422
Set id: a30388fa-0d85-4eb3-babd-228170ebe96d
Version: 2
Effective Time: 20171030
 
Richmond Pharmaceuticals, Inc.