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NDC 54738-0092-30 Chewable Acetaminophen 80 mg/1 Details

Chewable Acetaminophen 80 mg/1

Chewable Acetaminophen is a ORAL TABLET, CHEWABLE 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: 54738-0092-30
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	54738-0092
Product ID	54738-092_5cc5fab2-77b5-05c5-e053-2991aa0a272d
Associated GPIs	64200010000505
GCN Sequence Number	004494
GCN Sequence Number Description	acetaminophen TAB CHEW 80 MG ORAL
HIC3	H3E
HIC3 Description	ANALGESIC/ANTIPYRETICS,NON-SALICYLATE
GCN	16971
HICL Sequence Number	001866
HICL Sequence Number Description	ACETAMINOPHEN
Brand/Generic	Generic
Proprietary Name	Chewable Acetaminophen
Proprietary Name Suffix	Childrens
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	80
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 54738-0092-30 (54738009230)

Pricing Information	N/A
NDC Package Code	54738-092-30
Billing NDC	54738009230
Package	30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (54738-092-30)
Marketing Start Date	2015-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a5dd9031-a960-4a98-ab71-05b079183f1a Details

Active ingredient (in each tablet)

Acetaminophen 80 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:
headache
sore throat
flu
toothache
the common cold
temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:

more than 5 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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 your child is allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if your child has

liver disease.

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

pain gets worse or lasts more than 5 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.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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

this product does not contain directions or complete warnings for adult use
do not give more than directed
find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
chew before swallowing; this product will soften in mouth for ease of chewing
repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours
do not give for more than 5 days unless directed by a doctor

Weight (lb)	Age (yr)	Dose (tablets)*
Under 24	Under 2	Ask a doctor
24-35	2-3	2
36-47	4-5	3
48-59	6-8	4
60-71	9-10	4-5
72-95	11-12	4-6

*or as directed by a doctor

Other information

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
avoid high humidity
Phenylketonurics:each tablet contains: phenylalanine 5mg

Inactive ingredients

aspartame, compressible sugar, D&C red #27(Al lake), dextorse, FD&C yellow #6(Al lake), fruit flavor, magnesium stearate, microcrystaline cellulose, prosweet, stearice 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- 54738-092-30 - APAP 80MG CHEWABLE- 30 TABS

INGREDIENTS AND APPEARANCE

CHEWABLE ACETAMINOPHEN CHILDRENS

acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54738-092
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	80 mg

Ingredient Name	Strength
Inactive Ingredients
ASPARTAME (UNII: Z0H242BBR1)
INVERT SUGAR (UNII: ED959S6ACY)
D&C RED NO. 27 (UNII: 2LRS185U6K)
DEXTROSE (UNII: IY9XDZ35W2)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	pink (light)	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor	FRUIT	Imprint Code	AP;051
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54738-092-30	30 in 1 BOTTLE, PLASTIC; 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(54738-092)

Revised: 10/2017

Document Id: 5cc5fab2-77b5-05c5-e053-2991aa0a272d

Set id: a5dd9031-a960-4a98-ab71-05b079183f1a

Version: 2

Effective Time: 20171030