ABATUSS DMX- dexchlorpheniramine maleate, dextromethorphan hydrobromide, pseudoephedrine hydrochloride liquid

ABATUSS DMX by

Drug Labeling and Warnings

ABATUSS DMX by is a Otc medication manufactured, distributed, or labeled by Kramer Novis. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (per 5 mL )

Dexchlorpheniramine Maleate 1 mg
Dextromethorphan HBr  15 mg
Pseudoephedrine HCl 30 mg

Purpose

Antihistamine
Cough Suppressant
Nasal Decongestant

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• sneezing
• itchy nose or throat
• runny nose
• itchy, watery eyes
• nasal congestion
• temporarily controls cough due to minor throat and bronchial irritation associated with inhaled irritants
• temporarily restores freer breathing through nose

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

heart disease  high blood pressure  thyroid disease  diabetes  a breathing problem such as emphysema or chronic bronchitis  glaucoma  difficulty in urination due to enlarged prostate gland  persistent or chronic  cough such as occurs with smoking, asthma, or emphysema  cough accompanied by excessive phlegm (mucus)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product  do not exceed recommended dosage  may cause drowsiness   alcohol, sedatives, and tranquilizers may increase the drowsiness effect  avoid alcoholic beverages    use caution when driving a motor vehicle or operating machinery marked may occur  excitability may occur especially in children

Stop use and ask a doctor if  nervousness, dizziness, or sleeplessness occur  cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.  symptoms do not improve within 7 days or are accompanied by fever

If pregnant or breastfeeding ask a health professional before use.

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

Directions:

• Adults and children 12 years of age and older: 2 teaspoonfuls (10 mL) every 6 hours, not to exceed 8 teaspoonfuls in 24 hours or as directed by a doctor
• Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 6 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by a doctor
• Children 2 to under 6 years of age: Consult a doctor

Other information

• Store at controlled room temperature 15°C-30°C (59°F-86°F)
• Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing

Inactive ingredients:

Citric acid, FD&C blue #1, FD&C Red #40, grape flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, sorbitol, sucralose.

SPL UNCLASSIFIED SECTION

*Contains the same active ingredients as Deltuss DMX®

Antihistamine
Cough Suppressant
Nasal Decongestant

Each 5 mL contains:

Dexchlorpheniramine Maleate ...................1 mg
Dextromethorphan HBr.............................15 mg
Pseudoephedrine HCl ...............................30 mg

Alcohol Free  Sugar Free

Gluten Free

Grape Flavor

Manufactured in the USA for Kramer Novis, San Juan, PR 00917. T: (787) 767-2072 www.kramernovis.com

* Deltuss DMX® is a registered trademark of Deliz Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Deliz Pharmaceutical Corp.

Packaging

INGREDIENTS AND APPEARANCE

ABATUSS DMX 
dexchlorpheniramine maleate, dextromethorphan hydrobromide, pseudoephedrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52083-625
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N)	DEXCHLORPHENIRAMINE MALEATE	1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
METHYLPARABEN (UNII: A2I8C7HI9T)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE (Grape Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52083-625-16	1 in 1 CARTON	05/25/2014
1		473 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/25/2014

Labeler - Kramer Novis (090158395)