Label: CHILDRENS CHEWABLE ACETAMINOPHEN- acetaminophen tablet, chewable
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- NDC Code(s): 53943-449-08
- Packager: Discount Drug Mart
- 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 August 16, 2022
If you are a consumer or patient please visit this version.
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- 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
- more than 5 doses in 24 hours, which is the maximum daily amount
-
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?
-
Principal display panel
NDC 53943-449-08
MAY CONTAIN ANTI-THEFT DEVICE
Discount
Drug
Mart
FOOD MARKET
AN EMPLOYEE OWNERSHIP COMPANYAges 2-11
Children's Chewable Acetaminophen
160 mg Chewable Tablets ι Pain Reliever/Fever ReducerAspirin Free
Ibuprofen FreeActual Size
Grape Flavor
†Compare to the active ingredient of CHILDREN'S TYLENOL®
24 CHEWABLE TABLETS
Chew or crush tablets completely before swallowing.†This product is not manufactured or distributed
by Johnson & Johnson Corporation, owner of the
registered trademark Children’s Tylenol®.
50844 REV0522A44908DISTRIBUTED BY: DRUG MART - FOOD FAIR
211 COMMERCE DRIVE, MEDINA, OH 44256
www.discount-drugmart.comSATISFACTION GUARANTEED
IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE
TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO
STORE, SEND REASON FOR DISSATISFACTION, NAME,
ADDRESS AND EMPTY PACKAGE TO:
DISCOUNT DRUG MART
211 COMMERCE DRIVE, MEDINA, OHIO 44256TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER
CAP IS BROKEN OR MISSING
Drug Mart 44-449
-
INGREDIENTS AND APPEARANCE
CHILDRENS CHEWABLE ACETAMINOPHEN
acetaminophen tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53943-449 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 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:53943-449-08 1 in 1 CARTON 01/13/2020 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 01/13/2020 Labeler - Discount Drug Mart (047741335) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(53943-449) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(53943-449) , pack(53943-449) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(53943-449) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(53943-449)