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NDC 68210-3100-04 ASSURED EXTRA STRENGTH ACETAMINOPHEN 500 mg/1 Details

ASSURED EXTRA STRENGTH ACETAMINOPHEN 500 mg/1

ASSURED EXTRA STRENGTH ACETAMINOPHEN is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by SPIRIT PHARMACEUTICALS LLC. 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: 68210-3100-04
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	68210-3100
Product ID	68210-3100_ee01b9b6-92c4-4d1d-e053-2995a90a9513
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	ASSURED EXTRA STRENGTH ACETAMINOPHEN
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	SPIRIT PHARMACEUTICALS LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	2023-12-31

Package

Package Images

NDC 68210-3100-04 (68210310004)

Pricing Information	N/A
NDC Package Code	68210-3100-4
Billing NDC	68210310004
Package	1 BOTTLE in 1 CARTON (68210-3100-4) / 40 TABLET in 1 BOTTLE
Marketing Start Date	2018-04-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 0c23eb36-ce7e-4e16-9298-73cb4ee2b398 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:
the common cold
headache
backache
minor pain of arthritis
toothache
muscular aches
premenstrual and menstrual cramps
temporarily reduces fever

SPL UNCLASSIFIED SECTION

Warnings

SPL UNCLASSIFIED SECTION

Liver Warning

This product contains acetaminophen. 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

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

SPL UNCLASSIFIED SECTION

Ask a doctor before use if you have liver disease

SPL UNCLASSIFIED SECTION

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
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.

Directions

do not take more than directed (see overdose warning)

adults and 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 use for more than 10 days unless directed by a doctor
children under 12 years	ask a doctor

Other information

each caplet contains: magnesium 0.43 mg
store between 20-25°C (68-77°F)
do not use if carton is opened or inner Safety Seal is broken or missing

Inactive ingredients

Hypermellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions or comments?

1-888-333-9792

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

PRINCIPAL DISPLAY PANEL - 500 mg Caplet Bottle

ASSURED TM

CompareTO THE ACTIVE INGREDIENT IN

EXTRA STRENGTH TYLENOL® CAPLETS†

EXTRA STRENGTH

Acetaminophen

Acetaminophen 500 mg

Pain Reliever/ Fever reducer

Actual Size

ASPIRIN FREE

40 CAPLETS

INGREDIENTS AND APPEARANCE

ASSURED EXTRA STRENGTH ACETAMINOPHEN

acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68210-3100
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
HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	S500
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68210-3100-4	1 in 1 CARTON	04/10/2018
1		40 in 1 BOTTLE; 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	04/10/2018

Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)

Revised: 11/2022

Document Id: ee01b9b6-92c4-4d1d-e053-2995a90a9513

Set id: 0c23eb36-ce7e-4e16-9298-73cb4ee2b398

Version: 5

Effective Time: 20221121

Search by Drug Name or NDC

NDC 68210-3100-04 ASSURED EXTRA STRENGTH ACETAMINOPHEN 500 mg/1 Details

ASSURED EXTRA STRENGTH ACETAMINOPHEN 500 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 68210-3100-04 (68210310004)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 0c23eb36-ce7e-4e16-9298-73cb4ee2b398 Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each caplet)

Purpose

Uses

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Do not use

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Overdose Warning

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 500 mg Caplet Bottle

INGREDIENTS AND APPEARANCE

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