Label: ENTEX LQ- guaifenesin and phenylephrine hydrochloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 54868-6241-0 - Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 66992-280
- 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 September 30, 2010
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients per teaspoon (5 mL)
- Purpose
- Uses
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WARNINGS
Do not exceed recommended dosage.
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s Disease), or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this drug.
- Ask a doctor before use if you have
- Stop use and ask a doctor if
- Do not take this product if you have
- If pregnant or breast-feeding,
- Keep out of reach of children
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Directions
Age Dose Adults and children over 12 years of age 1 teaspoonful (5mL) every 4 hours; Children 6 to under 12 years of age 1/2 teaspoonful (2.5 mL) every 4 hours; Children 2 to under 6 years of age 1/4 teaspoon (1.25mL) every 4 hours Children under 2 years of age Ask your doctor Do not exceed 6 doses in a 24 – hour period. - Inactive ingredients
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- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ENTEX LQ
guaifenesin and phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-6241(NDC:66992-280) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C RED NO. 33 (UNII: 9DBA0SBB0L) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) Product Characteristics Color red Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-6241-0 473 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/01/2011 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel