Label: ABATUSS DMX- dexchlorpheniramine maleate, dextromethorphan hydrobromide, pseudoephedrine hydrochloride liquid
- NDC Code(s): 52083-625-16
- Packager: Kramer Novis
- 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 November 26, 2018
If you are a consumer or patient please visit this version.
- Drug Facts
- Active ingredients (per 5 mL )
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- 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
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.
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
- Inactive ingredients:
SPL UNCLASSIFIED SECTION
*Contains the same active ingredients as Deltuss DMX®
Each 5 mL contains:
Dexchlorpheniramine Maleate ...................1 mg
Dextromethorphan HBr.............................15 mg
Pseudoephedrine HCl ...............................30 mg
• Alcohol Free • Sugar Free
• Gluten Free
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.
INGREDIENTS AND APPEARANCE
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)