Label: PHARBINEX- guaifenesin 400mg tablet
- NDC Code(s): 73057-379-04
- Packager: Ulai Health LLC
- 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 January 31, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
- WARNINGS
- Ask a doctor before use if you have
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
-
Directions
- take with a full glass of water
- this product can be administered without regard for the timing of the meals
- do not exceed 6 doses in 24 hours or as directed by a doctor
adults and children 12 years of age and over take 1 tablet every 4 hours as needed children 6 to under 12 years of age take ½ tablet every 4 hours as needed children under 6 years of age ask a doctor - Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PHARBINEX
guaifenesin 400mg tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73057-379 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE K30 (UNII: U725QWY32X) POVIDONE K90 (UNII: RDH86HJV5Z) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score 2 pieces Shape CAPSULE Size 18mm Flavor Imprint Code PH063 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73057-379-04 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/26/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/26/2019 Labeler - Ulai Health LLC (081181535)