Your browser does not support JavaScript! CARE ONE ARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN SALES COMPANY]
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CARE ONE ARTHRITIS PAIN RELIEF (acetaminophen) tablet, film coated, extended release
[American Sales Company]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Uses

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

Do not use

  • if you are allergic to acetaminophen
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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 for more than 10 days
  • fever gets worse or lasts for 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: Taking more than the recommended dose (overdose) may cause liver damage. 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 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 400, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

EASY TO OPEN CAP

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

TEMPORARY, MINOR

ARTHRITIS PAIN RELIEF

Acetaminophen Extended-Release Tablets, 650 mg/Pain Reliever - Fever Reducer

LASTS UP TO 8 HOURS

See New Warnings Information

650 mg EACH

*Capsule-Shaped Tablets

Arthritis Pain Relief Label Image 1

Arthritis Pain Relief Label Image 1

Arthritis Pain Relief Label Image 2

Arthritis Pain Relief Label Image 2

CARE ONE ARTHRITIS PAIN RELIEF 
acetaminophen tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41520-966
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
COLLOIDAL SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
POLYSORBATE 80 
POVIDONE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code L544
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-966-78100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07507712/15/2009
Labeler - American Sales Company (809183973)

Revised: 4/2010
 
American Sales Company

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