Label: TUSNEL DM- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
- NDC Code(s): 54859-517-16
- Packager: Llorens Pharmaceutical International Division, Inc.
- 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 June 9, 2019
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
Do not use if you are taking a 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 using this product.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- difficulty in urination due to enlargment of prostate gland
- a cough with too much phlegm (mucus)
- a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
Stop use and ask a doctor if you get
- nervousness, dizziness, or sleeplessness occur
- cough lasts for more than 7 days, comes back or occurs with a fever, rash or headache that lasts. These could be signs of a serious condition.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54859-517 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54859-517-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/01/2019 Labeler - Llorens Pharmaceutical International Division, Inc. (037342305) Registrant - Llorens Pharmaceutical International Division, Inc. (037342305) Establishment Name Address ID/FEI Business Operations Llorens Pharmaceutical International Division, Inc. 037342305 manufacture(54859-517)