Label: CHILDRENS PAIN AND FEVER- acetaminophen tablet, chewable
- NDC Code(s): 36800-449-08
- 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.
Updated December 7, 2019
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- 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
Ask a doctor 24-35 2-3 1 tablet 36-47 4-5 1 1/2 tablets
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
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®.
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007 ©TOPCO LNKA1118
Top Care 44-449
INGREDIENTS AND APPEARANCE
CHILDRENS PAIN AND FEVER
acetaminophen tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-449 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 (UNII: 2LRS185U6K) D&C RED NO. 30 (UNII: 2S42T2808B) DEXTRATES (UNII: G263MI44RU) ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) Product Characteristics Color PURPLE Score no score Shape ROUND Size 16mm Flavor GRAPE Imprint Code 44;449 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-449-08 1 in 1 CARTON 02/15/2019 1 24 in 1 BOTTLE; 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. 832867894 MANUFACTURE(36800-449) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(36800-449) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 PACK(36800-449) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(36800-449) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(36800-449)