FDA Label for Childrens Pain And Fever

Active Ingredient (In Each 5 Ml)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

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

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

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

• skin reddening
• blisters
• rash

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


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 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.

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.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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
  
• do not give more than directed
  
• shake well before using
• mL = milliliter; FL OZ = fluid ounce
• only use the dose cup provided
• find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
• repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours

Weight (lb)	Age (yr)	Dose (mL)*
Under 24	Under 2	Ask a doctor
24-35	2-3	5 mL
36-47	4-5	7.5 mL
48-59	6-8	10 mL
60-71	9-10	12.5 mL
72-95	11	15 mL

*or as directed by a doctor

Other Information

• each 5 mL contains: sodium 3 mg
  
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  
• see end flap for expiration date and lot number
  

Inactive Ingredients

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

Questions Or Comments?

1-888-423-0139

Principal Display Panel

TopCare_®
health
COMPARE TO CHILDREN'S TYLENOL^®
ORAL SUSPENSION ACTIVE INGREDIENT**
NDC 76162-079-36

children's
Pain & 
Fever

ACETAMINOPHEN,
160 mg per 5 mL
ORAL SUSPENSION
PAIN RELIEVER • FEVER REDUCER

• Aspirin Free
•Ibuprofen Free
•Alcohol Free

STRAWBERRY
FLAVOR

Ages 2
to
11 years

4 FL OZ (118 mL)

**This product is not manufactured or distributed by
Kenvue Inc., owner of the registered trademark
Children's Tylenol® Oral Suspension.
50844 ORG092207936
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO LNKA0623
QUESTIONS? 1-888-423-0139
[email protected]
www.topcarebrand.com

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

Scan here for more
information or
call 1-888-423-0139

DIRECTIONS:
STEP 1.
Shake well
before using
STEP 2.
Remove child
protective
cap
STEP 3.
Pour your
child’s dose
into the
dosing cup

Please see dosing chart or ask
a doctor for your child’s correct dose

TopCare 44-079 - topcare 44 079 1