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  5. Label Information: Childrens Pain And Fever

FDA Label for Childrens Pain And Fever

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. KEEP OUT OF REACH OF CHILDREN
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOUR CHILD HAS
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD IS
    9. WHEN USING THIS PRODUCT
    10. STOP USE AND ASK A DOCTOR IF
    11. OVERDOSE WARNING
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS?
    16. PRODUCT LABEL

Childrens Pain And Fever Product Label

The following document was submitted to the FDA by the labeler of this product Aptapharma 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



Drug Facts

Active ingredient
(in each 5 mL = 1 teaspoonful)

Acetaminophen 160 mg


Purpose



Pain reliever/fever reducer


Keep Out Of Reach Of Children



Keep out of reach of children.


Uses



temporarily

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


Warnings



Liver warning

This product contains acetaminophen.Severe liver damage may occur if your child takes:

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

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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • If your child is allergic to acetaminophen or any other of the inactive ingredients in this product.

Ask A Doctor Before Use If Your Child Has



liver disease.


Ask A Doctor Or Pharmacist Before Use If Your 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 than 3 days
  • new symptoms
  • redness or swelling is present  These could be signs of a serious condition.

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. (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



this product does not contain directions or complete warnings for adult use
shake well before using
mL = milliliter;   tsp = teaspoonful
find the right dose on the chart below. If possible, use weight to dose, otherwise, use age.
if needed, repeat dose every 4 hours while symptoms 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 (yr)                                        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 tsp0

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

60-71                                             9 - 10 years                                     12.5. mL (2 1/2 TSP)

72-95                                                  11 years                                     15 mL (3 tsp)

*or as directed by a doctor

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.                   


Other Information



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

Inactive Ingredients



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


Questions?



Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944


Product Label



SOUND BODY™

COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN'S TYLENOL® ORAL SUSPENSION

Children's

Pain and Fever

Acetaminophen

Oral Suspension
     Alcohol Free
    Ibuprofen Free
    Aspirin Free

For Ages 2 to 11

CHERRY FLAVORED

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

DO NOT USE IF PRINTED NECKBAND IA BROKEN OR MISSING

*This product is not manufactures or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Oral Suspension.

Manufactured by:
AptaPharma Inc.,
1533 Union Ave
Pennsauken, NJ 08110

V#5002632    ITEM#302

BX-003 Rev 1


AptaPharma ChildPainFever Label - AptaPharmaChildPainFever

AptaPharma ChildPainFever Label - AptaPharmaChildPainFever




* Please review the disclaimer below.