FDA Label for Chewable Acetaminophen Childrens
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOUR CHILD HAS
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD IS
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Chewable Acetaminophen Childrens Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health 110, Llc. Dba Leader. 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 Tablet)
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- headache
- sore throat
- flu
- toothache
- 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
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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.
When Using This Product
Do not exceed recommended dosage.
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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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
- find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
- chew before swallowing; this product will soften in mouth for ease of chewing
- 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 (tablets)* |
Under 24 | Under 2 | Ask a doctor |
24-35 | 2-3 | 1 |
36-47 | 4-5 | 1 1/2 |
48-59 | 6-8 | 2 |
60-71 | 9-10 | 2 1/2 |
72-95 | 11 | 3 |
*or as directed by a doctor
Other Information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- avoid high humidity
- see end flap for expiration date and lot number
Inactive Ingredients
citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose
Questions Or Comments?
1-800-426-9391
Principal Display Panel
LEADER™
NDC 70000-0309-1
Children’s | Ages 2-11
Chewable Acetaminophen
Acetaminophen, 160 mg | Pain Reliever / Fever Reducer
Grape
Flavor
Aspirin Free
Ibuprofen Free
24 CHEWABLE TABLETS
ACTUAL SIZE
COMPARE TO
CHILDREN’S TYLENOL®
active ingredient†
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TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER
CAP IS BROKEN OR MISSING
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Return to place of purchase if not satisfied.
CIN 5335328 REV. 5/17
†This product is not manufactured or distributed by Johnson & Johnson
Corporation, owner of the registered trademark Children’s Tylenol®.
50844 ORG101644908
DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
CARDINAL HEALTH, the Cardinal Health LOGO, LEADER,
and the Leader LOGO are trademarks or registered
trademarks of Cardinal Health.
* Please review the disclaimer below.