ARTHRITIS PAIN RELIEVER- acetaminophen tablet, extended release

Arthritis Pain Reliever by

Drug Labeling and Warnings

Arthritis Pain Reliever by is a Otc medication manufactured, distributed, or labeled by WALGREENS, TIME CAP LABORATORIES INC., MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each caplet)
Acetaminophen 650 mg

PURPOSE

Purpose
Pain reliever/fever reducer

INDICATIONS & USAGE

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

WARNINGS

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

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 DOCTOR

Ask a doctor before use if you have liver disease

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

STOP USE

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information
store between 20-25ºC (68-77ºF)
The FDA approved Dissolution methods differ from USP

INACTIVE INGREDIENT

Inactive ingredients carnauba wax, hydroxyethyl cellulose, hypromellose, povidone, pregelatinized starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, triacetin

QUESTIONS

Questions or comments?
Call 1-877-290-4008

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ARTHRITIS PAIN RELIEVER 
acetaminophen tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-9781
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
POVIDONE K30 (UNII: U725QWY32X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	white (White to off-white)	Score	no score
Shape	CAPSULE (Capsule-shaped tablet)	Size	19mm
Flavor		Imprint Code	71
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-9781-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2022
2	NDC: 0363-9781-42	1 in 1 CARTON	11/22/2022
2		24 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215486	09/28/2022

Labeler - WALGREENS (008965063)

Registrant - TIME CAP LABORATORIES INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(0363-9781)