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  5. Label Information: Childrens Tukol Acetaminophen Fever Reducer Pain Reducer

FDA Label for Childrens Tukol Acetaminophen Fever Reducer Pain Reducer

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTSACTIVE INGREDIENT(IN EACH 5 ML = 1 TEASPOONFUL)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF THE CHILD HAS
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. KEEP OUT OF REACH OF CHILDREN.
    11. OVERDOSE WARNING:
    12. DIRECTIONS *
    13. ATTENTION:
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS?
    17. CHILDREN'S TUKOL® FEVER PAIN PRODUCT LABEL

Childrens Tukol Acetaminophen Fever Reducer Pain Reducer Product Label

The following document was submitted to the FDA by the labeler of this product Genomma Lab Usa, 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.

Drug Factsactive Ingredient(In Each 5 Ml = 1 Teaspoonful)



Acetaminophen 160 mg


Purpose



Pain reliever/fever reducer


Uses



temporarily

  • reduces fever
  • relieves minor aches and pains due to:
  • the common cold
  • flu
  • headache
  • sore throat
  • toothache

Warnings



Liver warning: This product cantains acetaminophen. Severe liver damage may occur if your child takes

  • more than 5 doses in 24 hours which is the maxium daily amount
  • with other drugs containing acetaminophen

    • Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

      • If skin reaction occurs, stop use and seek medical help right away.

      Sore throat warning: if sore throat is severe, persists more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomitting, 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 containd acetaminophen, ask a doctor or pharmacist

Ask A Doctor Before Use If The Child Has



liver disease


Ask A Doctor Or Pharmacist Before Use If The Child Is



taking the blood thinning drug warfarin.


When Using This Product



do not exceed recommended dose (see overdose warning)


Stop Use And Ask A Doctor If



  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more tha 3 days
  • new symptoms occur
  • redness or swelling is present

    • These could be signs of a serious condition


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 (1-800-222-1222) right away.
Quick medical attention is critical even if you do not notice any signs or symptoms.


Directions *



  • product is not labeled with directions or complete warning for adult use
  • Shake well before using
  • 1mL = milliliter; tsp = teaspoonful
  • find the right dose on chart below. If posssible, use weight to dose: otherwise use age.
  • if needed, repeat dose every 4 hours while symptons last
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor

    • weight (lb)             age                             dose (mL or tsp)

    under  24              under 2 years              ask a doctor

    24 - 35                  2 - 3 years                  5 mL (1 tsp)

    36- 47                   4 - 5 years                   7.5 mL (1 1/2 tsp)

    48 - 59                  6 - 8 years                  10 mL (10 mL (2 tsp)

    60- 71                   9 - 10 years                 12.5 mg  (2 1/2 tsp)

    72 95                    11 years                       15 mL (3 tsp)

    use only enclosed dosing cup specfically designed for use with this product


Attention:



use only enclosed dosing cup specfically designed for use with this product


Other Information



  • each 5 mL (1 tsp) contains: sodium 3 mg
  • store between 20-25°C (68-77°F )
  • do not refrigerate
  • keep carton for complete Drug facts

Inactive Ingredients



anhydrous citric acid, butylparaben, FD&C red # 40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum


Questions?



Call 1-877-99-GENOM (43666)


Children's Tukol® Fever Pain Product Label



Children's Tukol®

Acetaminophen - Pain Reliever-Fever Reducer Oral Suspension

DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSION

NEW

Ages 2 - 11

Fever Reducer

Pain Reducer

CHERRY FLAVOR

4 FL OZ (118 mL)
160 mg per 5 mL

Distributer by
Genomma Lab USA Inc.,
Houston, TX 77027

BX--058

LOT No.

Exp.


* Please review the disclaimer below.