Label: PRESGEN- guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide syrup
- NDC Code(s): 52083-632-16
- Packager: Kramer Novis
- 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 October 15, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Do Not Use: in a child under 2 years of age
if you are 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 do not know if
your prescription drug contains an MAOI, ask a doctor or pharmacist before
taking this product.
Ask a doctor before use if you have heart disease, thyroid disease, high blood pressure, diabetes
trouble urinating due to enlargement of the prostate gland
cough that occurs with too much phlegm (mucus)
chronic bronchitis or emphysema
When using this product, do not exceed recommended dosage
Stop use and ask a doctor if
you get nervous, dizzy, or sleepless
symptoms do not get better within 7 days or are accompanied by fever
cough lasts more than 7 days, comes back, or is accompanied by fever,
rash, or persistent headache. These could be signs of a serious condition
- DOSAGE & ADMINISTRATION
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- Packaging
-
INGREDIENTS AND APPEARANCE
PRESGEN
guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-632 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) SUCRALOSE (UNII: 96K6UQ3ZD4) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Product Characteristics Color red (CHERRY RED) Score Shape Size Flavor CHERRY (SOUR CHERRY) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52083-632-16 480 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/28/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/28/2011 Labeler - Kramer Novis (090158395) Registrant - Kramer Novis (090158395)