Label: CHILDRENS ACCUDIAL PAIN RELIEVER/ FEVER REDUCER- acetaminophen suspension
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Contains inactivated NDC Code(s)
NDC Code(s): 45014-139-04 - Packager: Accudial Pharmaceutical, Inc.
- Category: HUMAN OTC DRUG LABEL
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 May 4, 2012
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL = 1 teaspoon)
- Purpose
- Uses
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Warnings
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.
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.
Ask a doctor before use if your child has liver disease.
Ask a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs.
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Directions
This product does not contain directions or complete warnings for adult use.
- shake well before using
- if needed, repeat dose every 4 hours
- do not use more than 5 times in 24 hours
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when weight is known: use the rotating bottle label to find the child's weight and read the correct dose. This is the most accurate dose.
when weight is unknown: use the age chart on the rotating label. - use only enclosed dosing syringe and adapter to dose this product. Do not use any other dosing device
Age (yr) Dose (mL or tsp) tsp. = teaspoon mL = milliliter under 6 mos. ask a doctor 6 mos. to under 2 2.5 mL or ½ tsp. 2 to under 4 5 mL or 1 tsp. 4 to under 6 7.5 mL or 1½ tsp. 6 to under 9 10 mL or 2 tsp. 9 to under 11 12.5 mL or 2½ tsp. 11 to under 12 15 mL or 3 tsp. or as directed by a doctor Ask a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs.
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
Children's
ACCUDIAL®Acetaminophen
Oral SuspensionPain Reliever / Fever Reducer
For ages 6 mos. to
under 12 yrs. or 12-95 lbs.Alcohol Free • Aspirin Free • Ibuprofen Free
Compares to the active
ingredient in Children's
Tylenol® Oral Suspension.ROTATING
LABEL FOR
WEIGHT-BASED
DOSINGDye-Free
Cherry
Flavor4 FL.OZ. (120 mL)
80 mg per 1/2 teaspoon
(160 mg per 5 mL)NDC 45014-139-04
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INGREDIENTS AND APPEARANCE
CHILDRENS ACCUDIAL PAIN RELIEVER/ FEVER REDUCER
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45014-139 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 160 mg in 5 mL Inactive Ingredients Ingredient Name Strength Cherry (UNII: BUC5I9595W) Citric Acid Monohydrate (UNII: 2968PHW8QP) Corn Syrup (UNII: 9G5L16BK6N) Glycerin (UNII: PDC6A3C0OX) Cellulose, Microcrystalline (UNII: OP1R32D61U) Carboxymethylcellulose Sodium (UNII: K679OBS311) Propylene Glycol (UNII: 6DC9Q167V3) Water (UNII: 059QF0KO0R) Sodium benzoate (UNII: OJ245FE5EU) Sucralose (UNII: 96K6UQ3ZD4) Sorbitol (UNII: 506T60A25R) Xanthan Gum (UNII: TTV12P4NEE) Product Characteristics Color RED Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45014-139-04 118 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part343 04/25/2012 Labeler - Accudial Pharmaceutical, Inc. (831999201)