Label: ACETAMINOPHEN tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 42254-155-30 - Packager: Rebel Distributors Corp
- This is a repackaged label.
- Source NDC Code(s): 0536-3233
- 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 February 16, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Keep Out of Reach of Children
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if the child takes
more than 5 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
Sore throat warning: If sore throat is severe, lasts for more than 2 days or is accompanied or fillowed 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.
Ask a doctor before use if the child has liver disease
Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin.
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
redness or swelling is present
any new symptoms appear
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Directions
this product does not contain directions or complete warnings for adult use
find correct does on chart below
if possible, use weight to dose, otherwise use age
chew tablets before swallowing
give dose every 4 hours while symptoms last
do not give more than 5 doses in 24 hours
Weight
(pounds)Age
(years)Dose
(tablets)72 - 95 11 - 12 4 - 6 60 - 71 9 - 10 4 - 5 48 - 59 6 - 8 4 36 - 47 4 - 5 3 24 - 35 2 - 3 2 under 24 under 2 ask a doctor - Inactive ingredients
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42254-155(NDC:0536-3233) 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 ASPARTAME (UNII: Z0H242BBR1) SUCROSE (UNII: C151H8M554) D&C RED NO. 27 (UNII: 2LRS185U6K) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color PINK (Light) Score no score Shape ROUND Size 8mm Flavor Imprint Code Logo;051 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42254-155-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 02/16/2012 Labeler - Rebel Distributors Corp (118802834) Registrant - PSS World Medical, Inc. (101822862) Establishment Name Address ID/FEI Business Operations PSS World Medical, Inc. 791528623 REPACK(42254-155) Establishment Name Address ID/FEI Business Operations STAT RX USA LLC 786036330 REPACK(42254-155) Establishment Name Address ID/FEI Business Operations Dispensing Solutions, Inc. 066070785 RELABEL(42254-155) , REPACK(42254-155) Establishment Name Address ID/FEI Business Operations SCRIPT PAK 964420108 RELABEL(42254-155) , REPACK(42254-155) Establishment Name Address ID/FEI Business Operations Keltman Pharmaceuticals, Inc. 362861077 REPACK(42254-155) Establishment Name Address ID/FEI Business Operations Rebel Distirbutors Corp. 118802834 RELABEL(42254-155) , REPACK(42254-155)
