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Arthritis 8 Hour

Medically reviewed on September 25, 2017

Dosage form: tablet, film coated, extended release
Ingredients: ACETAMINOPHEN 650mg
Labeler: Safeway Inc.
NDC Code: 21130-336

Drug Facts

ACTIVE INGREDIENT (IN EACH CAPLET)

Acetaminophen USP, 650 mg

PURPOSE

Pain reliever/fever reducer

USES
  • temporarily relieves minor aches and pains due to:
    • muscular aches
    • backache
    • headache
    • toothache
    • minor pain of arthritis
  • 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
  • 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.
  • if you have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets.

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: 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 and children 12 years and overtake 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
    children under 12 yearsdo not use

OTHER INFORMATION
  • store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F).
  • see end panel for batch number and expiration date
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

INACTIVE INGREDIENTS

Croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

8 Hour

Use only as directed.

NDC 21130-336-01

Pain Relief

Compare to Tylenol®8 Hour active ingredient

Acetaminophen

Extended-Release Tablets, USP

Pain Reliever/Fever Reducer

  • For up to 8 Hour Relief of Minor Muscle Aches & Pain

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

100 CAPLETS*650 mg EACH(*capsule-shaped tablets)

SAFEWAY®

DISTRIBUTED BY SAFEWAY INC.

5091297/R1011

ARTHRITIS 8 HOUR 
acetaminophen tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-336
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
STARCH, PREGELATINIZED CORN 
PROPYLENE GLYCOL 
SODIUM LAURYL SULFATE 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeOVAL (Capsule Shaped) Size19mm
FlavorImprint Codecor116
Contains    
Packaging
#Item CodePackage Description
1NDC:21130-336-01100 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07620004/30/2002
Labeler - Safeway Inc. (009137209)
Registrant - Ohm Laboratories Inc. (051565745)
Establishment
NameAddressID/FEIOperations
Ohm Laboratories Inc.184769029manufacture(21130-336)

 
Safeway Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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