Good Sense Pain Relief Arthritis Pain: Package Insert and Label Information

GOOD SENSE PAIN RELIEF ARTHRITIS PAIN- acetaminophen tablet, film coated, extended release
L. Perrigo Company

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)
do not use if printed foil under cap is broken or missing
meets the requirements of USP Dissolution Test 2

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

Push & Turn Cap

Arthritis Pain

Acetaminophen Extended-Release Tablets, 650 mg

Pain Reliever / Fever Reducer

For the Temporary Relief of Minor Arthritis Pain

24 Caplets* — 650 mg EACH

*Capsule-Shaped Tablets

Compare to active ingredient of Tylenol® 8HR Arthritis Pain

100% SATISFACTION GUARANTEED

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(click image for full-size original)
GOOD SENSE PAIN RELIEF ARTHRITIS PAIN
acetaminophen tablet, film coated, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0113-0544
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
MAGNESIUM STEARATE
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYSORBATE 80
POVIDONE
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 19mm
Flavor Imprint Code L544
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0113-0544-62 1 BOTTLE in 1 CARTON contains a BOTTLE
1 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE This package is contained within the CARTON (0113-0544-62)
2 NDC:0113-0544-71 1 BOTTLE in 1 CARTON contains a BOTTLE
2 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE This package is contained within the CARTON (0113-0544-71)
3 NDC:0113-0544-78 1 BOTTLE in 1 CARTON contains a BOTTLE
3 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE This package is contained within the CARTON (0113-0544-78)
4 NDC:0113-0544-79 400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075077 11/21/2005
Labeler — L. Perrigo Company (006013346)

Revised: 07/2019 L. Perrigo Company

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