Label: CHILDRENS PAIN AND FEVER- acetaminophen tablet, chewable
- NDC Code(s): 36800-450-08
- Packager: Topco Associates, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 28, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each chewable tablet)
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
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
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.
- 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?
Principal display panel
COMPARE TO CHILDREN’S
TYLENOL® ACTIVE INGREDIENT†
Pain & Fever
ACETAMINOPHEN 160 mg, CHEWABLE TABLETS
PAIN RELIEVER • FEVER REDUCER
• Ibuprofen Free • Aspirin Free
Chew or crush tablets completely before swallowing.
24 CHEWABLE TABLETS
For Ages 2 to 11 Years
TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER
CAP IS BROKEN OR MISSING
†This product is not manufactured or distributed by Johnson &
Johnson Corporation, owner of the registered trademark Children’s
Tylenol®. 50844 REV0522B45008
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007 ©TOPCO LNKA0521
Visit here for more information: http://topbrnds.com/48ZZSF
INGREDIENTS AND APPEARANCE
CHILDRENS PAIN AND FEVER
acetaminophen tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-450 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 (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) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color pink Score 2 pieces Shape ROUND Size 16mm Flavor BUBBLE GUM Imprint Code 44;450 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-450-08 1 in 1 CARTON 02/15/2019 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 not final part343 02/15/2019 Labeler - Topco Associates, LLC (006935977) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(36800-450) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(36800-450) , pack(36800-450) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(36800-450) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(36800-450)