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NDC 54738-0540-01 APAP 500 mg/1 Details

APAP 500 mg/1

APAP is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Richmond Pharmaceuticals, Inc.. The primary component is ACETAMINOPHEN.

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 54738-0540-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	54738-0540
Product ID	54738-540_5cc3aaa6-e1aa-a116-e053-2991aa0a1422
Associated GPIs	64200010000315
GCN Sequence Number	004490
GCN Sequence Number Description	acetaminophen TABLET 500 MG ORAL
HIC3	H3E
HIC3 Description	ANALGESIC/ANTIPYRETICS,NON-SALICYLATE
GCN	16965
HICL Sequence Number	001866
HICL Sequence Number Description	ACETAMINOPHEN
Brand/Generic	Generic
Proprietary Name	APAP
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	500
Active Ingredient Units	mg/1
Substance Name	ACETAMINOPHEN
Labeler Name	Richmond Pharmaceuticals, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	2024-12-31

Package

Package Images

NDC 54738-0540-01 (54738054001)

Pricing Information	N/A
NDC Package Code	54738-540-01
Billing NDC	54738054001
Package	100 TABLET in 1 BOTTLE (54738-540-01)
Marketing Start Date	2015-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ad087586-67cd-4875-b0e6-3fba06ea0f65 Details

Active Ingredient

(in each caplet)

Acetaminophen 500 mg

Purpose

Pain Reliever / Fever Reducer

Uses

temporarily relieves minor aches and pains due to:

headache
muscular aches
backache
minor pain of arthritis
the common cold
toothache
premenstrual and menstrual cramps
temporarily reduces fever

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

more than 4,000 mg of acetaminophen in 24 hours
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 non prescription). 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 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

pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur

these could be signs of a serious condition.

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

Do not take more than directed (see over dose warning) adults & children 12 years and over :
take 2 caplets every 6 hours while symptoms last
do not take more than 6 caplets in 24 hours, unless directed by a doctor
do not take for more than 10 days unless directed by a doctor
children under 12 years : ask 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

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: 54738-540-01 ..100 APAP 500mg tabs

NDC: 54738-540-03 ..1000 APAP 500mg tabs

INGREDIENTS AND APPEARANCE

APAP

acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54738-540
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Ingredient Name	Strength
Inactive Ingredients
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	AP;013
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:54738-540-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2015
2	NDC:54738-540-03	1000 in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	04/01/2015

Labeler - Richmond Pharmaceuticals, Inc. (043569607)

Registrant - Advance Pharmaceutical Inc. (078301063)

Name	Address	ID/FEI	Business Operations
Establishment
Advance Pharmaceutical Inc.		078301063	manufacture(54738-540)

Revised: 10/2017

Document Id: 5cc3aaa6-e1aa-a116-e053-2991aa0a1422

Set id: ad087586-67cd-4875-b0e6-3fba06ea0f65

Version: 2

Effective Time: 20171030