Label: ACETAMINOPHEN liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 54868-1791-0 - Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0182-1473
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 December 7, 2009
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
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 product containing acetaminophen
- more than directed (see overdose warning)
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Directions
- find right dose on chart
- if possible, use weight to dose; otherwise, use age
- if needed, repeat dose every 4 hours
- do not use more than 5 times in 24 hours
Weight Age Dose under 24 lbs under 2 years ask a doctor 24 to 35 lbs 2 to 3 years 1 teaspoon (5 mL) 36 to 47 lbs 4 to 5 years 1 ½ teaspoons (7.5 mL) 48 to 59 lbs 6 to 8 years 2 teaspoons (10 mL) 60 to 71 lbs 9 to 10 years 2 ½ teaspoons (12.5 mL) 72 to 95 lbs 11 years 3 teaspoons (15 mL) - Other information
- Inactive ingredients
- Questions?
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PRINCIPAL DISPLAY PANEL
ACETAMINOPHEN
ORAL SOLUTION USP
160 mg/5 mL
PAIN RELIEVER - FEVER REDUCER
Alcohol-Free
Aspirin-Free
Saccharin-Free
Cherry-FlavoredEACH TEASPOON (5 mL) CONTAINS:
Acetaminophen USP 160 mgTAMPER-EVIDENT: Do not use this product if
inner foil seal over the mouth of the bottle
is cut, torn, broken or missing.THIS PACKAGE FOR HOUSEHOLDS
WITHOUT YOUNG CHILDRENDistributed by:
GOLDLINE LABORATORIES, INC.
Sellersville, PA 18960
Dist. 1990 0809REV 71Relabeling of "Additional Barcode Label" by:
Physicians Total Care, Inc.
Tulsa, OK 74146NDC 54868-1791-0
TAMPER-EVIDENT
ONE PINT (473 mL)
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-1791(NDC:0182-1473) 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 BENZOIC ACID (UNII: 8SKN0B0MIM) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCROSE (UNII: C151H8M554) 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:54868-1791-0 473 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 07/07/2004 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel