Label: PRESGEN PEDIATRIC- guaifenesin, phenylephrine hcl,dextromethorphan hydrobromide syrup
- NDC Code(s): 52083-653-16
- Packager: KRAMER NOVIS
- 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.
Updated December 13, 2018
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- Drug Facts
- Active Ingredients (in each 5 ml tsp):
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive.
Temporarily relieves :
• nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis)
• cough due to minor throat and bronchial irritation as may occur with the common cold
Do not use
• in a child under 2 years of age.
• in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Ask a doctor before use if your child has
• heart disease • high blood pressure
• thyroid disease • diabetes
• 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.
When using this product do not exceed recommended dosage.
Stop use and ask a doctor if
• your child gets 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.
If pregnant or breast-feeding, ask a health professional before use.
- Other information
- Inactive Ingredients:
SPL UNCLASSIFIED SECTION
Compare to Tussi-Pres Pediatric®
SUGAR AND ALCOHOL FREE
SACCHARIN & SORBITOL FREE
Manufactured in the USA for Kramer-Novis, San Juan, PR 00917
Tel: (787) 767-2072 www.kramernovis.com
INGREDIENTS AND APPEARANCE
guaifenesin, phenylephrine hcl,dextromethorphan hydrobromide syrup
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-653 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 75 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor ORANGE (CITRUS ORANGE) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52083-653-16 480 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/24/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/24/2011 Labeler - KRAMER NOVIS (090158395) Registrant - KRAMER NOVIS (090158395)