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  5. Label Information: Arthritis Pain Reliever

FDA Label for Arthritis Pain Reliever

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH CAPLET)
    3. PURPOSE
    4. USES
    5. LIVER WARNING
    6. ALLERGY ALERT
    7. DO NOT USE
    8. OTC - ASK DOCTOR
    9. OTC - ASK DOCTOR/PHARMACIST
    10. STOP USE AND ASK A DOCTOR IF
    11. OTC - PREGNANCY OR BREAST FEEDING
    12. OTC - KEEP OUT OF REACH OF CHILDREN
    13. OVERDOSE WARNING
    14. DIRECTIONS
    15. OTHER INFORMATION
    16. INACTIVE INGREDIENTS
    17. QUESTIONS?
    18. PRINCIPAL DISPLAY PANEL - 650 MG CAPLET BOTTLE CARTON

Arthritis Pain Reliever Product Label

The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

Distributed by McKesson Corp.,
via Strategic Sourcing Services LLC,
Memphis, TN 38141


Active Ingredient (In Each Caplet)



Acetaminophen USP, 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

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.

Otc - Ask Doctor



Ask a doctor before use if you have liver disease.


Otc - Ask Doctor/Pharmacist



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.


Otc - Pregnancy Or Breast Feeding



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


Otc - 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.


Directions



  • •do not take more than directed (see overdose warning)
    • 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 doctorask a doctor

    adults

    ••••

    under 18 years of age

    •

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



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


Questions?



Call 833-358-6431


Principal Display Panel - 650 Mg Caplet Bottle Carton



sunmark®

EASY TO OPEN BOTTLE

COMPARE TO TYLENOL® ARTHRITIS PAIN ACTIVE INGREDIENT
NDC 70677-0147-1

arthritis pain reliever

Acetaminophen Extended-release Tablets USP, 650 mg

Pain Reliever/Fever Reducer

For the Temporary Relief of Minor Arthritis Pain

THIS PACKAGE FOR HOUSEHOLDS
WITHOUT YOUNG CHILDREN

LASTS UP TO 8 HOURS

Use only as directed.

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

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

Principal Display Panel - 650 mg Caplet Bottle Carton - acetaminophen 01

Principal Display Panel - 650 mg Caplet Bottle Carton - acetaminophen 01


* Please review the disclaimer below.