Label: TUSSLIN TR- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet
- NDC Code(s): 52083-617-10
- 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 26, 2017
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- ACTIVE INGREDIENT
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
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.
INGREDIENTS AND APPEARANCE
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet
Product 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)