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NDC 52083-0625-16 ABATUSS DMX 1; 15; 30 mg/5mL; mg/5mL; mg/5mL Details
ABATUSS DMX 1; 15; 30 mg/5mL; mg/5mL; mg/5mL
ABATUSS DMX is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Kramer Novis. The primary component is DEXCHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE.
Product Information
| NDC | 52083-0625 |
|---|---|
| Product ID | 52083-625_a0f9bf55-af76-4bbb-bb71-648d1f9a0da3 |
| Associated GPIs | 43995803490930 |
| GCN Sequence Number | 069264 |
| GCN Sequence Number Description | dexchlorphenir/pseudoephed/DM LIQUID 1-30-15/5 ORAL |
| HIC3 | B3R |
| HIC3 Description | NON-OPIOID ANTITUS-1ST GEN.ANTIHISTAMINE-DECONGEST |
| GCN | 32254 |
| HICL Sequence Number | 039060 |
| HICL Sequence Number Description | DEXCHLORPHENIRAMINE MALEATE/PSEUDOEPHED/DEXTROMETHORPHAN HBR |
| Brand/Generic | Generic |
| Proprietary Name | ABATUSS DMX |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 1; 15; 30 |
| Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
| Substance Name | DEXCHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Labeler Name | Kramer Novis |
| Pharmaceutical Class | Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 52083-0625-16 (52083062516)
| NDC Package Code | 52083-625-16 |
|---|---|
| Billing NDC | 52083062516 |
| Package | 1 BOTTLE in 1 CARTON (52083-625-16) / 473 mL in 1 BOTTLE |
| Marketing Start Date | 2014-05-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 6d54ef1e-6722-43f9-a0a7-14a786160b04 Details
Active ingredients (per 5 mL )
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.
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
Inactive ingredients:
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.
INGREDIENTS AND APPEARANCE
| ABATUSS DMX
dexchlorpheniramine maleate, dextromethorphan hydrobromide, pseudoephedrine hydrochloride liquid |
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| Labeler - Kramer Novis (090158395) |
| Registrant - Kramer Novis (090158395) |