SIMPLY RIGHT ARTHRITIS PAIN- acetaminophen tablet, film coated, extended release 
Sam's West Inc

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Sam’s West, Inc. Arthritis Pain Drug Facts

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?

1-800-809-0469

Principal Display Panel

arthritis pain relief

arthritis pain

acetaminophen extended-release tablets 650 mg

pain reliever/fever reducer

Compare to Tylenol® 8HR Arthritis Pain active ingredient

for the temporary relief of minor arthritis pain

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

See new warning

actual size

200 caplets*

650 mg each

*(capsule-shaped tablets)

Arthritis Pain Label
SIMPLY RIGHT ARTHRITIS PAIN 
acetaminophen tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-463
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONES (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULE (caplet) Size19mm
FlavorImprint Code L544
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68196-463-82200 in 1 BOTTLE; Type 0: Not a Combination Product01/28/201204/27/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07507701/28/201204/27/2017
Labeler - Sam's West Inc (051957769)

Revised: 3/2018
 
Sam's West Inc