Label: KROGER CHILDREN PAIN PLUS FEVER CHEWABLES- acetaminophen tablet, chewable
- NDC Code(s): 41226-061-24
- Packager: KROGER COMPANY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 25, 2024
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- Official Label (Printer Friendly)
- Active ingredient (in each chewable tablet)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:
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- more than 5 doses in 24 hours, which is the maximum daily amount
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- with other drugs containing acetaminophen
Allergy Alert: acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blister
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- 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
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- if your child is allergic to acetaminophen or any of the inactive ingredients in this product.
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Directions
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- this product does not contain directions or complete warnings for adult use.
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- do not give more than directed (see overdose warning)
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- chew or crush tablets completely before swallowing
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- find the right dose on chart below. If possible, use weight to dose; otherwise use age.
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- repeat dose every 4 hours while symptoms last
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- do not give more than 5 times in 24 hours
Weight (lb)
under 24
24-35
36-47
48-59
60-71
72-95
Age (yr)
under 2 years
2-3 years
4-5 years
6-8 years
9-10 years
11 years
Dose (Tablets)
ask a doctor
1 tablet
1 ½ tablets
2 tablets
2 ½ tablets
3 tablets
*or as directed by a doctor
- Other information
- Inactive ingredients
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Principal Display Panel
NDC 41226-061-24
Compare to active ingredient in Children’s Tylenol® Chewables*
Children’s Pain + Fever Chewables
ACETAMINOPHEN 160mg Per Tablet
Pain Reliever/Fever Reducer
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- Aspirin free
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- Ibuprofen Free
Chew or crush tablets completely before swallowing
Ages 2-11Grape Flavor
Naturally and Artificially Flavored
24 CHEWABLE TABLETS 160 mg eachTAMPER EVIDENT:DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
IMPORTANT: Keep this carton for future reference on full labeling.
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark children’s Tylenol® Chewable.
DIST. BY:
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INGREDIENTS AND APPEARANCE
KROGER CHILDREN PAIN PLUS FEVER CHEWABLES
acetaminophen tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41226-061 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 (120 .MU.M) (UNII: 68401960MK) D&C RED NO. 30 (UNII: 2S42T2808B) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) STARCH, CORN (UNII: O8232NY3SJ) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color PURPLE Score 2 pieces Shape ROUND Size 16mm Flavor GRAPE Imprint Code RP160 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41226-061-24 4 in 1 CARTON 04/08/2024 1 6 in 1 BLISTER PACK; 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 04/08/2024 Labeler - KROGER COMPANY (006999528)