Label: CHEWABLE ACETAMINOPHEN CHILDRENS- acetaminophen tablet, chewable
- NDC Code(s): 70000-0309-1
- Packager: Cardinal Health 110, LLC. DBA Leader
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 18, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each chewable tablet)
- Purpose
- Uses
-
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
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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 or crush tablets completely before swallowing; do not swallow tablets whole
- 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 (chewable tablets)* Under 24 Under 2 Ask a doctor 24-35 2-3 1 tablet 36-47 4-5 1 1/2 tablets 48-59 6-8 2 tablets 60-71 9-10 2 1/2 tablets 72-95 11 3 tablets *or as directed by a doctor
- Other information
- Inactive ingredients
- Questions or comments?
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Principal display panel
LEADER™
NDC 70000-0309-1
Children's
Chewable Acetaminophen
160 mg Chewable Tablets | Pain Reliever / Fever ReducerGrape Flavor
Ages 2 - 11
Aspirin-Free
Ibuprofen-Free
Chew or crush tablets
completely before swallowing.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 MISSING100% Money Back Guarantee
Return to place of purchase if not satisfied.CIN 5335326 REV. 9/22
**This product is not manufactured or distributed by Johnson & Johnson
Corporation, owner of the registered trademark Children’s Tylenol®.
50844 REV0522B44908DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com
1-800-200-6313©2022 CARDINAL HEALTH, LEADER, and
LOGOs are trademarks of Cardinal
Health. All other marks are the property
of their respective owners.Leader 44-449
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INGREDIENTS AND APPEARANCE
CHEWABLE ACETAMINOPHEN CHILDRENS
acetaminophen tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0309 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) D&C RED NO. 30 (UNII: 2S42T2808B) DEXTROSE MONOHYDRATE (UNII: LX22YL083G) ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color purple Score 2 pieces Shape ROUND Size 16mm Flavor GRAPE Imprint Code 44;449 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0309-1 1 in 1 CARTON 01/28/2005 1 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 01/28/2005 Labeler - Cardinal Health 110, LLC. DBA Leader (063997360) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(70000-0309) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(70000-0309) , pack(70000-0309) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(70000-0309) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(70000-0309)