ACTINEL DM- dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

ACTINEL DM by

Drug Labeling and Warnings

ACTINEL DM by is a Otc medication manufactured, distributed, or labeled by ACTIPHARMA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients (in each 5 mL tsp)

Dextromethorphan HBr, USP.....20 mg

Guaifenesin, USP......................400 mg

Phenylephrine HCl, USP............10 mg

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Uses

Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes  Temporarily relieves these symptoms occurring with a cold:  nasal congestion  cough due to minor throat and bronchial irritation.

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  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.

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not take more than 6 doses in any 24-hour period.

• Adults and Children 12 years of age and over: 5mL (1tsp), every 4 hours
• Children under 12 years of age: ask a doctor

Other information

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:

Artificial and natural flavors, citric acid, glycerin, menthol, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate and sucralose.

SPL UNCLASSIFIED SECTION

Contains the same active ingredients as Tusnel® DM*

SUGAR FREE

DYE FREE

ALCOHOL FREE

Great Flavor

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.

Packaging

INGREDIENTS AND APPEARANCE

ACTINEL DM 
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)