Label: PECGEN DMX - guaifenesin and dextromethorphan hydrobromide syrup
- NDC Code(s): 52083-620-16
- Packager: KRAMER NOVIS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- ACTIVE INGREDIENT
Active Ingredients/5 ml: guaifenesin 125 mg dextromethorphan hydrobromide 15 mgClose
Cough suppressant, expectorantClose
- INDICATIONS & USAGE
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive. restores free breathing.
suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritantsClose
• use more than the recommended dose
• give this product to a child who has heart disease, high blood pressure, thyroid
disease, or diabetes unless directed by a doctor.
• 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 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.
• diabetes • heart disease • thyroid disease • high blood pressure • trouble
urinating due to an enlarged prostate gland • cough that occurs with too much
phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking,
asthma, chronic bronchitis or emphysema.
Ask a doctor before use if you have
When using this product do not use more than directed
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
•Coughs lasts more than 7 days, comes back, or is accompanied by fever, rash, or a
persistent headache. These could be signs of a serious condition.
- KEEP OUT OF REACH OF CHILDREN
Keep this and all medicines out of the reach of childrenClose
- PREGNANCY OR BREAST FEEDING
As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this productClose
- INACTIVE INGREDIENT
Inactives: Citric Acid, FDC Red 40, Flavor, Glycerin, Methylparaben, propylene Glycol, Propylparaben, Purified Water, Sodium Citrate, SucraloseClose
- PRINCIPAL DISPLAY PANEL
- DOSAGE & ADMINISTRATION
Directions Adults and Children 12 years of age and over 10 mL (2 tsp)
Children 6 to under 12 years of age 5 mL (1 tsp) E V E RY
do not take more than 4 doses in any 24-hour period
- INGREDIENTS AND APPEARANCE
guaifenesin,dextromethorphan hydrobromide syrup
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-620 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 125 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg in 5 mL Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor CHERRY (SWEET C HERRY) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52083-620-16 480 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/29/2011 Labeler - KRAMER NOVIS (090158395) Registrant - KRAMER NOVIS (090158395) Establishment Name Address ID/FEI Business Operations ULTRAtab Laboratories, Inc. 151051757 manufacture(52083-620) Establishment Name Address ID/FEI Business Operations Ultra Seal Corporation 085752004 repack(52083-620)