1. Home
  2. Labeler Index
  3. One2zee Limited Liability Company
  4. 55629-718
  5. Label Information: Acetaminophen (red)

FDA Label for Acetaminophen (red)

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH CAPSULE)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. OTC - ASK DOCTOR
    8. OTC - ASK DOCTOR/PHARMACIST
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. OVERDOSE WARNING
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. PRINCIPAL DISPLAY PANEL - SHIPPING LABEL

Acetaminophen (red) Product Label

The following document was submitted to the FDA by the labeler of this product One2zee Limited Liability Company. 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


Active Ingredient (In Each Capsule)



Acetaminophen 325 mg


Purpose



Pain reliever/ fever reducer


Uses



• Temporarily relieves minor aches and pains due to :

     ◦ headache
     ◦ muscular aches
     ◦ backache
     ◦ minor pain of arthritis
     ◦ the common cold
     ◦ toothache
     ◦ premenstrual and menstrual cramps  

• Temporarily reduces fever


Warnings



Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 softgels (3,250 mg) in 24 hours for adults or 5 softgels (1,625 mg) in 24 hours for children. Severe liver damage may occur if
• adult takes more than 4,000 mg of acetaminophen in 24 hours
• child takes more than 5 doses in 24 hours, which is the maximum daily amount
• taken with other drugs containing acetaminophen
• adult has 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

Otc - Ask Doctor



Ask a doctor before use if the user has liver disease


Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin


Stop Use And Ask A Doctor If



  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • 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
(seeOverdose warning)

 adults and children 12 years and over
  • take 2 softgels every 4 to 6 hours while symptoms last
  • do not take more than 10 softgels in 24 hours
  • do not use for more than 10 days unless directed by a doctor
 children 6-11 years
  • take 1 softgel every 4 to 6 hours while symptoms last
  • do not take more than 5 softgels in 24 hours
  • do not use for more than 5 days unless directed by a doctor
 children under 6 years ask a doctor


Other Information



store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat


Inactive Ingredients



FD&C red #40, gelatin, sorbitol, glycerin, polyethylene glycol 400, povidone K-30, propylene glycol, titanium dioxide, purified water


Principal Display Panel - Shipping Label



ACETAMINOPHEN CAPSULES, 325 mg

Quantity : 48 Bags of 300 Capsules each
NDC. No : 55629-718-01

Important:

1. Inspect immediately upon receipt

2. This is bulk shipment intended for further processing only
3. Store at controlled temperature of 59°F to 86°F (15°C to 30°C) avoid high humidity and excessive heat above 104°F (40°C)


* Please review the disclaimer below.