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NDC 00404-0714-99 Henry Schein Acetaminophen 325 mg/1 Details

Henry Schein Acetaminophen 325 mg/1

Henry Schein Acetaminophen is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Henry Schein, 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: 00404-0714-99
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	00404-0714
Product ID	0404-0714_dee72182-b3c7-42c5-e053-2995a90a83ce
Associated GPIs
GCN Sequence Number	004489
GCN Sequence Number Description	acetaminophen TABLET 325 MG ORAL
HIC3	H3E
HIC3 Description	ANALGESIC/ANTIPYRETICS,NON-SALICYLATE
GCN	16964
HICL Sequence Number	001866
HICL Sequence Number Description	ACETAMINOPHEN
Brand/Generic	Generic
Proprietary Name	Henry Schein Acetaminophen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	325
Active Ingredient Units	mg/1
Substance Name	ACETAMINOPHEN
Labeler Name	Henry Schein, 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 00404-0714-99 (00404071499)

Pricing Information	N/A
NDC Package Code	0404-0714-99
Billing NDC	00404071499
Package	2 TABLET, FILM COATED in 1 PACKET (0404-0714-99)
Marketing Start Date	2008-12-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f43f72de-ff79-4c7e-bd1e-3f0c4c3872fa Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

Acetaminophen 325 mg

SPL UNCLASSIFIED SECTION

Purpose

Pain reliever/fever reducer

SPL UNCLASSIFIED SECTION

Uses

temporarily relieves minor aches and pains due to:

headache
muscular aches
minor pain of arthritis
backaghe
the common cold
toothache
premenstral and menstrual cramps

temporarily reduces fever

SPL UNCLASSIFIED SECTION

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

more than 4,000 mg in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

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.

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 you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have

liver disease

Ask a doctor or pharmacist before use if

you are taking the blood thinning drug warfarin

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if

pain gets worse or lasts for more than 10 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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Keep out of reach of children.

Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

SPL UNCLASSIFIED SECTION

Directions

do not use more than directed

Adults and children: (12 years and over)

take 2 tablets every 4 to 6 hours while symptoms last.
do not take more than 10 tablets in 24 hours
do not use for more than 10 days unless directed by a doctor

Children under 12 years: Ask a doctor

SPL UNCLASSIFIED SECTION

Other information

store at room temperature 59°-86°F (15°-30°C)
tamper-evident sealed packets
do not use any opened or torn packets

SPL UNCLASSIFIED SECTION

Inactive ingredients

corn starch, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments? 1-800-472-4346

PRINCIPAL DISPLAY PANEL

Henry Schein®

Acetaminophen

For the temporary relief of minor aches and pains

associated with the headache, muscular aches, minor arthritis pain,

common cold, toothache, menstrual cramps and for the reduction of fever.

Henry Schein Seal of Excellence®

Pull to Open

This Package is for Households without Young Children.

Reorder

900-4689

Acetaminophen 325 mg

250 Packets/2 Tablets

INGREDIENTS AND APPEARANCE

HENRY SCHEIN ACETAMINOPHEN

acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0404-0714
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (ROUND)	Size	10mm
Flavor		Imprint Code	AZ;234
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0404-0714-99	2 in 1 PACKET; Type 0: Not a Combination Product	12/30/2008
2	NDC:0404-0714-13	250 in 1 BOX	12/30/2008
2		2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	12/30/2008

Labeler - Henry Schein, Inc. (012430880)

Registrant - Unifirst First Aid Corporation (832947092)

Revised: 5/2022

Document Id: dee72182-b3c7-42c5-e053-2995a90a83ce

Set id: f43f72de-ff79-4c7e-bd1e-3f0c4c3872fa

Version: 8

Effective Time: 20220513

Search by Drug Name or NDC

NDC 00404-0714-99 Henry Schein Acetaminophen 325 mg/1 Details

Henry Schein Acetaminophen 325 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00404-0714-99 (00404071499)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL f43f72de-ff79-4c7e-bd1e-3f0c4c3872fa Details

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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