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NDC 52083-0622-16 Tusslin 28; 388; 10 mg/5mL; mg/5mL; mg/5mL Details
Tusslin 28; 388; 10 mg/5mL; mg/5mL; mg/5mL
Tusslin is a ORAL SYRUP in the HUMAN OTC DRUG category. It is labeled and distributed by Kramer Novis. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 52083-0622-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 52083-0622-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 52083-0622-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 52083-0622 |
|---|---|
| Product ID | 52083-622_84c38749-284a-42f4-8a7b-9daf89a96c85 |
| Associated GPIs | 43997303100933 |
| GCN Sequence Number | 065716 |
| GCN Sequence Number Description | guaifen/dextromethorphan/PE LIQUID 388-28-10 ORAL |
| HIC3 | B4R |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-DECONGESTANT-EXPECTORANT |
| GCN | 27747 |
| HICL Sequence Number | 000216 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR/PHENYLEPHRINE |
| Brand/Generic | Generic |
| Proprietary Name | Tusslin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SYRUP |
| Route | ORAL |
| Active Ingredient Strength | 28; 388; 10 |
| Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Kramer Novis |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 52083-0622-16 (52083062216)
| NDC Package Code | 52083-622-16 |
|---|---|
| Billing NDC | 52083062216 |
| Package | 474 mL in 1 BOTTLE (52083-622-16) |
| Marketing Start Date | 2014-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 14a6e659-f97b-44c2-bcf7-5e017c7f4001 Details
Active Ingredients (in each 5 mL tsp)
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
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.
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
INGREDIENTS AND APPEARANCE
| TUSSLIN
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride syrup |
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| Labeler - Kramer Novis (090158395) |
| Registrant - Kramer Novis (090158395) |