Label: GILPHEX- guaifenesin, phenylephrine hcl tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 66576-336-01 - Packager: Syntho Pharmaceuticals, Inc.
- 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 June 13, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Purposes
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Uses
Temporarily relieves the symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies.
Helps loosen phlegm (mucus), loosens nasal congestion, thin bronchial secretions, drain bronchial tubes, make coughs more productive,clear stuffy nose,clear nasal passageways, shrinks swollen membranes. -
Warnings
Do not use this product more than the recommended dosage, or 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 2 weeks after stopping the MAOI drug.
If you are uncertain whether your prescription drug contains an MAOI, ask a health professional. - Ask a doctor before use if you have
- Stop use and ask a doctor If
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other Information
- Inactive Ingredients
- Questions? Call 787-848-9114
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GILPHEX
guaifenesin, phenylephrine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66576-336 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 390 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 10 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape CAPSULE Size 8mm Flavor Imprint Code 304;Gil Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66576-336-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/05/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/05/2022 Labeler - Syntho Pharmaceuticals, Inc. (088797407)