Active Ingredients (In Each Tablet)
Acetaminophen 160 mg
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 110, Llc. Dba Leader for the product Chewable Acetaminophen (NDC 70000-0310). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 160 mg
Pain reliever/fever reducer
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
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.
liver disease.
taking the blood thinning drug warfarin.
do not exceed recommended dosage.
These could be signs of a serious condition.
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.
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
citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, flavor, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose
1-800-426-9391
LEADER™
NDC-70000-0310-1
Children's ι Ages 2-11
Chewable Acetaminophen
Acetaminophen, 160 mg ι Pain Reliever / Fever Reducer
Bubblegum
Flavor
Aspirin Free
Ibuprofen Free
24 CHEWABLE TABLETS
ACTUAL SIZE
COMPARE TO
CHILDREN'S TYLENOL®
active ingredient†
100% Money Back Guarantee
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
All LEADER™ Brand Products Have A
100% Money Back Guarantee
Return to place of purchase if not satisfied.
CIN 5335336 REV. 5/17
†This product is not manufactured or distributed by Johnson &
Johnson Corporation, owner of the registered trademark Children's
Tylenol®.
50844 ORG021745008
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OH 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.