![TUSSLIN (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) SYRUP [KRAMER NOVIS]](https://medic.hrt.org//dailymed/images/14a6e659-f97b-44c2-bcf7-5e017c7f4001/52083622-1.jpg)
| NDC | 52083-622-16 |
| Set ID | 14a6e659-f97b-44c2-bcf7-5e017c7f4001 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Kramer Novis |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Drug Facts
- Active Ingredients (in each 5 mL tsp)
- Purposes
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Uses
- 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
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Warnings
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.
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Directions
• 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
- Packaging
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INGREDIENTS AND APPEARANCE
TUSSLIN
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrupProduct 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)
