Label: CHILDREN PAIN AND FEVER RELIVER- acetaminophen tablet, chewable
- NDC Code(s): 11673-240-24
- Packager: Target Corporation
- 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 January 15, 2020
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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.
acetaminophen may cause severe skin reaction. Symptom may include:
- skin reddening
- 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.
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
- Other information
- Inactive ingredients
Principal Display Panel
Compare to active ingredient in Children’s Tylenol® Chewables*
Chewable tabs, 160 mg
pain reliever/fever reducer
AGES 2-11 YEARS
Naturally and Artificially Flavored
24 CHEWABLE TABLETS
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Junior Strength Tylenol® Meltaways®.
IMPORTANT: Keep this carton for future reference on full labeling.
Distributed by Target Corporation
Minneapolis, MN 55403
© 2014 Target Brands, Inc.
INGREDIENTS AND APPEARANCE
CHILDREN PAIN AND FEVER RELIVER
acetaminophen tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-240 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) STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) D&C RED NO. 27 (UNII: 2LRS185U6K) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) MALTODEXTRIN (UNII: 7CVR7L4A2D) MAGNESIUM STEARATE (UNII: 70097M6I30) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color PINK Score 2 pieces Shape ROUND Size 16mm Flavor BUBBLE GUM Imprint Code RP160 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-240-24 4 in 1 CARTON 11/11/2019 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 11/11/2019 Labeler - Target Corporation (006961700)