Label: PREMIER VALUE CHILDRENS ACETAMINOPHEN MELTS- acetaminophen tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 68016-196-00 - Packager: Chain Drug Consortium
- 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 January 16, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 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
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
Stop use and ask a doctor if
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- pain gets worse or lasts more than 5 days
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- fever gets worse or lasts more than 3 days
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- new symptoms occur
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- redness or swelling is present
These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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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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- find the right dose on chart. If possible, use weight to dose; otherwise, use age.
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- Chew before swallowing; this product will soften in mouth for ease of chewing
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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
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- do not give for more than 5 days unless directed by a doctor
Weight (lb)
Age (yr)
Dose (tablets)*
Under 24
Under 2 years
ask a doctor
24-35
2-3 years
2 tablets
36-47
4-5 years
3 tablets
48-59
6-8 years
4 tablets
60-71
9-10 years years
5 tablets
72-95
11
6 tablets
- Other information
- Inactive ingredients
- Questions or comments?
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Product Packaging
NDC 68016-196-00
Compare to Children's Tylenol® Meltaways® Active Ingredient*
Premier Value
Children's
Pain RelieverAges 2-6
ACETAMINOPHENpain reliever/fever reducer
Aspirin Free/ Ibuprofen FreeGRAPE FLAVOR
30 count – 80mg each
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Tylenol® Meltaways®.
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INGREDIENTS AND APPEARANCE
PREMIER VALUE CHILDRENS ACETAMINOPHEN MELTS
acetaminophen tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-196 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 80 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. 30 (UNII: 2S42T2808B) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) MALTODEXTRIN (UNII: 7CVR7L4A2D) MAGNESIUM STEARATE (UNII: 70097M6I30) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color PURPLE Score no score Shape ROUND Size 13mm Flavor GRAPE Imprint Code RP080 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-196-00 1 in 1 CARTON 1 30 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 12/06/2004 Labeler - Chain Drug Consortium (101668460)