Label: ACTINEL DM- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
- NDC Code(s): 63102-104-16
- Packager: Actipharma, 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 May 23, 2019
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- Drug Facts
- Active Ingredients (in each 5 mL tsp)
• 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 • 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 exceed recommended dosage
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 • coughs lasts more than 7 days, come back, or is accompanied by fever, rash, or a persistent headache. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
• Store at room temperature 15°- 30°C (59°- 86°F) • protect from freezing • protect from light • Avoid excessive heat or humidity. TAMPER EVIDENT: Do not use if inner seal is torn, broken or missing. Pharmacist: Preserve and dispense in tight, light-resistant container with a child resistant cap as defined in the USP.
- Inactive ingredients:
SPL UNCLASSIFIED SECTION
Contains the same active ingredients as Tusnel® DM*
Manufactured in the USA for ActiPharma, Inc. Dorado, PR 00646. Tel: (787)608-0882
* Tusnel® DM is a registered trademark of Llorens Pharmaceutical. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical.
INGREDIENTS AND APPEARANCE
dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63102-104 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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63102-104-16 474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/20/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/20/2019 Labeler - Actipharma, Inc (079340948)