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  5. Label Information: Acetaminophen

FDA Label for Acetaminophen

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH 5 ML = 1 TEASPOONFUL)
    2. PURPOSE
    3. USES
    4. LIVER WARNING
    5. SORE THROAT WARNING:
    6. DO NOT USE
    7. OTC - ASK DOCTOR
    8. OTC - ASK DOCTOR/PHARMACIST
    9. OTC - WHEN USING
    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. OTHER
    17. INACTIVE INGREDIENTS:
    18. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acetaminophen Product Label

The following document was submitted to the FDA by the labeler of this product Akron Pharma 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 5 Ml = 1 Teaspoonful)



Acetaminophen 160 mg


Purpose



Pain Reliever/Fever Reducer


Uses



To reduce fever and for the temporary relief of 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.


Liver Warning



This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 6 doses in 24 hours, which is the maximum daily amount
  • 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 everyday while using this product.


Sore Throat Warning:



If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.


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 your child is allergic to acetaminophen or any of the inactive ingredients in this product

Otc - Ask Doctor



Ask a doctor before use if your child has

  • liver disease
  • is on a sodium-restricted diet.

Otc - Ask Doctor/Pharmacist



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


Otc - When Using



When using this product: Do not exceed recommended dose


Stop Use And Ask A Doctor If:



  • Pain gets worse or lasts more than 5 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:



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/children even if you do not notice any signs or symptoms.


Directions



  • shake well before using
  • find the right dose on chart below, if possible, use weight to dose; otherwise use age
  • dosage may be repeated every 4 hours, or as directed by your doctor
  • do not use more than 5 doses in 24 hours
  • do not use more than 5 days unless directed by a doctor.
  • find right dose on chart below, If possible, use weight to dose; otherwise, use age.
    • Weight (lbs.)          Age (years)             dosage-teaspoonful (tsp.)
     under 24 under 2 consult Physician
     24 to 35 2 to 3 1 tsp. (5 mL)
     36 to 47 4 to 5 1 1/2 tsp. (7.5 mL)
     48 to 59 6 to 8 2 tsp. (10 mL)
     60 to 71 9 to 10 2 1/2 tsp. (12.5 mL)
     72 to 95 11 3 tsp. (15 mL)


Other Information



  • Store at room temperature 15°-30° C (59°-86°F)
  • Protect from Freezing. 
  • Protect from Light.

Other



TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.


Inactive Ingredients:



Bubble Gum Flavor, Citric Acid, FD C RED #40, Glycerin, Polyethylene Glycol 400, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol Solution 70% & Sodium Benzoate.

Questions or Comments?

Call (877) 225-6999 Monday - Friday 9AM-5PM EST

Manufactured for
Akron Pharma, Inc.,
Fairfeld, NJ - 07004

Rev 09-19

Manufactured In USA

* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol Elixir


Package Label.Principal Display Panel



4 Oz

4oz - 4oz

4oz - 4oz

8 Oz


* Please review the disclaimer below.