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  5. Label Information: Arthritis Pain Reliever

FDA Label for Arthritis Pain Reliever

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS?
    15. PRINCIPAL DISPLAY PANEL – CARTON – 650 MG
    16. PRINCIPAL DISPLAY PANEL – BLISTER – 650 MG

Arthritis Pain Reliever Product Label

The following document was submitted to the FDA by the labeler of this product American Health Packaging. 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.

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:
    • 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



  • Supplied as unit dose packages of 30 (5 x 6) NDC 68084-777-25
  • store at 20° to 25°C (68° to 77°F). Avoid excessive heat 40°C (104°F).
  • FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Inactive Ingredients



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


Questions?



  • about Acetaminophen, USP 650 mg call Ranbaxy Pharmaceuticals, Inc. at 1-800-406-7984
  • about the packaging call American Health Packaging at 1-800-707-4621

    • Contains No Aspirin

    PACKAGING INFORMATION
    American Health Packaging unit dose blisters contain drug product from Ohm Laboratories Inc. as follows:
    (650 mg / 30 UD) NDC 68084-777-25 packaged from NDC 51660-333

    Distributed by: American Health Packaging, 2550 John Glenn Avenue, Suite A, Columbus, OH 43217

    8277725/0216OS


Principal Display Panel – Carton – 650 Mg



NDC 68084-777-25

Acetaminophen
Extended-release Tablets, USP
Pain Reliever/Fever Reducer

DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN.

650 mg

30 Tablets (5 x 6)

Drug Facts
Active Ingredient                                          Purpose
(in each caplet)
Acetaminophen USP, 650 mg            Pain reliever/fever reducer

Uses
See package insert for complete Drug Facts information.

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.

Keep out of reach of children.

See package insert for additional Drug Facts warnings.

Directions
• do not take more than directed, see package insert for
overdose warning and complete Drug Facts information.

Other Information• store at 20° to 25°C (68° to
77°F). Avoid excessive heat 40°C (104°F). • FOR YOUR
PROTECTION: Do not use product if blister is torn or
broken.

Contains No Aspirin

The drug product contained in this package is
from NDC # 51660-333, Ohm Laboratories Inc.

Distributed by: American Health Packaging,
2550 John Glenn Avenue, Suite A, Columbus,
OH 43217

077725
0277725/0216OS


Principal Display Panel – Blister – 650 Mg



Acetaminophen
Extended-release
Tablet, USP
Pain Reliever/
Fever Reducer

650 mg


* Please review the disclaimer below.