NDC | 52083-617-10 |
Set ID | d38d627e-441f-49f6-b05d-75750944e97d |
Category | HUMAN OTC DRUG LABEL |
Packager | KRAMER NOVIS |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
Uses • temporarily relieves cough due to minor throat or 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 coughs more productive • temporarily relieves nasal congestion due to a cold, hay fever or other respiratory allergies, reduces swelling of nasal passages; shrinks swollen membranes
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WARNINGS
Warning • Do not use if you are 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 if you have • diabetes • heart disease • Thyroid disease • high blood pressure • 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 use more than directed.
Stop use and ask a doctor if • nervousness, dizziness or sleeplessness occur • symptoms do not get better within 7 days or are accompanied by fever • coughs lasts more than 7 days, comes back, or is accompanied by fever, rash, or a persistent headache. These could be signs of a serious condition.
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- INACTIVE INGREDIENT
-
DOSAGE & ADMINISTRATION
Directions • do not exceed recommended doses in a 24 hour period.
• Adults and Children 12 years of age and over. 1 tablet every 6-8 hours. Do not exceed 4 tablets in 24 hours.
• Children 6 to under 12 years of age: 1⁄2 tablet every 6-8 hours. Do not exceed 2 tablets in 24 hours.
• Children under 6 years of age: ask physician.
- Packaging
-
INGREDIENTS AND APPEARANCE
TUSSLIN TR
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52083-617 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 28 GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 388 PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score 2 pieces Shape OVAL Size 17mm Flavor Imprint Code tr Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52083-617-10 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/04/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/04/2015 Labeler - KRAMER NOVIS (090158395) Registrant - KRAMER NOVIS (090158395)