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

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.

----------

ABATUSS DMX Antihistamine Cough Suppressant Nasal Decongestant GRAPE Flavor

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:

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 older2 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 age1 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

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.

*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

image description

ABATUSS DMX 
dexchlorpheniramine maleate, dextromethorphan hydrobromide, pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-625
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorGRAPE (Grape Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52083-625-161 in 1 CARTON05/25/2014
1473 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/25/2014
Labeler - Kramer Novis (090158395)

Revised: 11/2018
Document Id: 32925058-b3c8-412c-af68-53461291d917
Set id: 6d54ef1e-6722-43f9-a0a7-14a786160b04
Version: 2
Effective Time: 20181126
 
Kramer Novis