Label: TUSSI PRES PEDIATRIC- guaifenesin, phenylephrine hcl,dextromethorphan hydrobromide syrup
- NDC Code(s): 52083-232-01, 52083-232-04, 52083-232-05, 52083-232-16
- 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 6, 2018
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- SPL UNCLASSIFIED SECTION
- Active Ingredients (In each 5 mL teaspoon)
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 taking 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), or cough that lasts or is chronic such as occurs with asthma, chronic bronchitis or emphysema.
Do not use more than the recommended dose.
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.
Do not take more than 6 doses in any 24-hour period.
Adults & Children 12 years of age and older Take 4 teaspoons (20 mL) every 4 hours, as needed. Children 6 to under 12 years of age Take 2 teaspoons (10 mL) every 4 hours, as needed. Children 2 to under 6 Take one pre-measured single dose package (1 teaspoon or 5 mL) every 4 hours, as needed. Children under 2 years Do not use.
- Other Information:
- Inactive Ingredients:
- SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
TUSSI PRES PEDIATRIC
guaifenesin, phenylephrine hcl,dextromethorphan hydrobromide syrup
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-232 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:52083-232-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/24/2011 07/12/2017 2 NDC:52083-232-04 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/24/2011 07/12/2017 3 NDC:52083-232-16 480 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/24/2011 4 NDC:52083-232-05 5 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/21/2012 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)