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NDC 70677-0018-01 Sunmark Arthritis Pain Reliever 650 mg/1 Details

Sunmark Arthritis Pain Reliever 650 mg/1

Sunmark Arthritis Pain Reliever is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services 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: 70677-0018-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	70677-0018
Product ID	70677-0018_7c525608-c31c-48fa-adb7-7ae0bc8e6d69
Associated GPIs	64200010000420
GCN Sequence Number	022123
GCN Sequence Number Description	acetaminophen TABLET ER 650 MG ORAL
HIC3	H3E
HIC3 Description	ANALGESIC/ANTIPYRETICS,NON-SALICYLATE
GCN	16910
HICL Sequence Number	001866
HICL Sequence Number Description	ACETAMINOPHEN
Brand/Generic	Generic
Proprietary Name	Sunmark Arthritis Pain Reliever
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	650
Active Ingredient Units	mg/1
Substance Name	ACETAMINOPHEN
Labeler Name	Strategic Sourcing Services LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA075077
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70677-0018-01 (70677001801)

Pricing Information
NDC Package Code	70677-0018-1
Billing NDC	70677001801
Package	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70677-0018-1)
Marketing Start Date	2017-05-26
NDC Exclude Flag	N
Price Per Unit	0.06585
Pricing Unit	EA
Effective Date	2022-11-23
NDC Description	SM ARTHRITIS PAIN ER 650 MG TB
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2022-11-23

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 704bff95-1295-47af-a89e-880223499978 Details

Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

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

•: more than 6 caplets 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

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.

If pregnant or breast-feeding,

ask a health professional before use.

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	• take 2 caplets every 8 hours with water • swallow whole; do not crush, chew, split or dissolve • do not take more than 6 caplets in 24 hours • do not use for more than 10 days unless directed by a doctor
under 18 years of age	• ask a doctor

Other information

•: store at 20-25°C (68-77°F). Avoid excessive heat 40°C (104°F).

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

sunmark®

COMPARE TO TYLENOL® 8HR ARTHRITIS PAIN ACTIVE INGREDIENT

See New Warning

arthritis pain reliever

Acetaminophen

Extended-Release Tablets, 650 mg

Pain reliever/Fever reducer

For the Temporary Relief of Minor Arthritis Pain

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

100 CAPLETS* - 650 mg EACH

GLUTEN FREE

*Capsule-Shaped Tablets

INGREDIENTS AND APPEARANCE

SUNMARK ARTHRITIS PAIN RELIEVER

acetaminophen tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70677-0018
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	L544
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70677-0018-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/26/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA075077	05/26/2017

Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 11/2022

Document Id: 7c525608-c31c-48fa-adb7-7ae0bc8e6d69

Set id: 704bff95-1295-47af-a89e-880223499978

Version: 4

Effective Time: 20221116