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  5. Label Information: Apap

FDA Label for Apap

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. KEEP OUT OF REACH OF CHILDREN.
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. QUESTIONS OR COMMENTS
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Apap Product Label

The following document was submitted to the FDA by the labeler of this product Richmond Pharmaceuticals, Inc.. 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.

Active Ingredient



(in each caplet)

Acetaminophen 500 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 6 caplets (3,000 mg) in 24 hours. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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 non prescription). 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 the 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
      • redness or swelling is present
      • new symptoms occur

        • 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. 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 over dose warning) adults & children 12 years and over :
  • take 2 caplets every 6 hours while symptoms last
  • do not take more than 6 caplets in 24 hours, unless directed by a doctor
  • do not take for more than 10 days unless directed by a doctor
  • children under 12 years : ask a doctor

Other Information



  • store at 15-30 °C (59-86 °F)

Inactive Ingredients



polyvinylpyrrolidone, pregelatinized corn starch, sodium starch glycolate, stearic acid


Questions Or Comments



call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING


Package Label.Principal Display Panel



NDC: 54738-540-01 ..100 APAP 500mg tabs

IMG_4679 - IMG 4679

IMG_4679 - IMG 4679

NDC: 54738-540-03 ..1000 APAP 500mg tabs


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