Label: CHILDREN PAIN AND FEVER RELIEVER- acetaminophen tablet, chewable
- NDC Code(s): 41250-244-24
- Packager: MEIJER DISTRIBUTION INC
- 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 31, 2022
If you are a consumer or patient please visit this version.
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- 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 reaction. 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 (see overdose warning)
- find the right dose on chart below. If possible, use weight to dose; otherwise use age.
- chew completely do not swallow whole
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
under 2 years
ask a doctor
1 ½ tablets
2 ½ tablets
*or as directed by a doctor
- Other information
- Inactive ingredients
Principal Display Panel
Compare to active ingredient in Children’s Tylenol® Chewables*
Children’s Pain Fever Chewables
Pain reliever/Fever reducer
For Ages 2-11 Years
Naturally and Artificially Flavored
24 CHEWABLE TABLETS 160 mg each
TAMPER 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.
MEIJER DISTRIBUTION, INC
GRAND RAPIDS, MI 49544
INGREDIENTS AND APPEARANCE
CHILDREN PAIN AND FEVER RELIEVER
acetaminophen tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-244 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:41250-244-24 4 in 1 CARTON 01/29/2020 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 not final part343 01/29/2020 Labeler - MEIJER DISTRIBUTION INC (006959555)