Label: TUSSLIN- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrup
- NDC Code(s): 52083-622-16
- 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 January 6, 2021
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- Drug Facts
- Active Ingredients (in each 5 mL tsp)
- suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make cough more productive • temporarily relieves nasal congestion due to a cold
Do not 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.
Ask a doctor before use if you have
• heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to the enlarged prostate gland • cough that occurs with too much phlegm (mucus) • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.
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 • 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.
• Take every 6 hours, or as directed by a doctor.
Adults and children 12 years of age and older Take one teaspoonful (5 mL). Do not exceed 4 teaspoonfuls in 24 hours Children 6 to under 12 years of age Take 1/2 teaspoonful (2.5 mL). Do not exceed 2 teaspoonfuls in 24 hours Children 2 to under 6 years of age Take 1/4 teaspoonful (1.25 mL). Do not exceed 1 teaspoonful in 24 hours Children under 2 years of age Consult a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrup
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-622 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 28 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 388 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) WATER (UNII: 059QF0KO0R) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color PURPLE (clear, purple) Score Shape Size Flavor GRAPE (artificial grape flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52083-622-16 474 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/01/2014 Labeler - Kramer Novis (090158395) Registrant - Kramer Novis (090158395)