BIO Dtuss
- Manufacturer
- Advanced Generic Corporation
- Effective date
- 2024-12-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-06-01 00:47:40
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients(in each 5 mL tsp.) Purpose
Brompheniramine Maleate...................... 1mg ..................................Antihistamine
Dextromethorphen HBr........................... 20 mg ............................Cough Suppressant
Pseudoephedrine HCl............................. 30mg .............................Nasal Decongestant
OTC - PURPOSE SECTION
Uses:
- Temporarily relieves cough due to minor throat and bronchial irritation as may occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies or associated with sinusitis
- Temporarily relieves these symptoms due to hay fever(allergies rhinitis)
- Runny nose
- Sneezing
- Itchy, watery eyes
- Itchy of the nose or throat
- Temporarily restores free breathing through the nose
WARNINGS SECTION
Warnings:
- May cause excitability especially in children. May cause drowsiness, alcohol, sedatives and tranquilizers may increase the drowsiness effect. Avoid alcohol beverages while taking this product. Do not take this product if you have taken sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.
- Do not exceed recommended dosage. 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 you are taking a prescription drug that contains an MAOI; ask your doctor or pharmacist before taking this product.
OTC - DO NOT USE SECTION
Do Not Use:
Ask a doctor before use if you have:
- Cough that occurs with too much phlegm (mucus)
- Heart disease
- High blood pressure
- Thyroid disease
- Diabetes
- Glaucoma
- Trouble urinating due to an enlarged prostate gland
- A breathing problem or persistent or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
Stop use and ask a doctor if:
- You get nervous, dizzy or sleepless
- Symptoms do not get better within 7 days, comes back, or is accompaniend by fever, rash or persistent headache. These could be signs of a serious condition
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding,ask a health professional before use.
DOSAGE & ADMINISTRATION SECTION
Directions:
| adults and children 12 years of age and over
| take 1 teaspoonfull every 6 hours
|
| children 6 to under 12 years of age
| take 1/2 teaspoonfull every 6 hours
|
| children under 6 years of age
| ask doctor
|
INDICATIONS & USAGE SECTION
Other Information:
store at room temperature 15-30 degrees celcius (59-86 degrees farenheit)
Tamper Evident FeatureDo not use if seal under cap(or cello band over cap) is torn, broken or missing
INACTIVE INGREDIENT SECTION
Inactive Ingredients:
Glycerin, Propylene Glycol, Methylparaben, Propylparaben, Sucrose, Citric Acid, Sodium Citrate, D and C Red #33, FD and C Blue #1, Grape Flavor and Purified Water.
OTC - QUESTIONS SECTION
Question and Comments?1-305-403-3788
Advanced Generic Corporation, Miami, FL 33166
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1245722 | brompheniramine maleate 1 MG / dextromethorphan HBr 20 MG / pseudoephedrine HCl 30 MG in 5 mL Oral Solution | PSN | 6 |
| 1245722 | brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 4 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution | SCD | 6 |
| 1245722 | brompheniramine maleate 1 MG / dextromethorphan hydrobromide 20 MG / pseudoephedrine hydrochloride 30 MG per 5 ML Oral Solution | SY | 6 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PSEUDOEPHEDRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| e974e22d-8688-7d92-1e87-40c1079e170c | Product name | 3 | 20151125 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 30c51294-7ae9-8007-7de6-58222684a0be | Product name | 1 | 20140508 |
| 4f26f669-fc6c-40ef-9e26-1c7b2390ee66 | Product name | 1 | 20140508 |
| 70a83adc-6047-bbea-5a08-dfd304aa47d2 | Product name | 1 | 20140508 |
| 858ce051-9941-aafc-8c7c-44a8e0227463 | Product name | 1 | 20140508 |
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 45737-203-16 | 2020-12-23 | C162847 | 48780-1 | 9d75b9d0-3fe5-f424-e053-dadaa90a57ce | AGC- BioDTussDMX 203 |
| 45737-203-16 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3fe5-f424-e053-dadaa90a57ce | AGC- BioDTussDMX 203 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 45737-203-16 | BIO DtussDMX | 473 mL in 1 BOTTLE | LIQUID | 473 | 6 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 45737-203-16 | ML - Milliliter | 45737-203 | de65ba53-2cc3-457c-81d0-310f9ed812c9 | 1 | 2020-04-20 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BROMPHENIRAMINE MALEATE | ACTIVE INGREDIENT | IXA7C9ZN03 | 2 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 2 | |
| PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 6V9V2RYJ8N | 2 | |
| BROMPHENIRAMINE | ACTIVE MOIETY | H57G17P2FN | 2 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 2 | |
| PSEUDOEPHEDRINE | ACTIVE MOIETY | 7CUC9DDI9F | 2 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 2 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | 2 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Products#
Every source-derived product name is available through these pages.
- BIO Dtuss DMX
- Brompheniramine Maleate, Dextromethorphan, Pseudoephedrine
- GLYCERIN
- PROPYLENE GLYCOL
- METHYLPARABEN
- PROPYLPARABEN
- SUCROSE
- CITRIC ACID MONOHYDRATE
- SODIUM CITRATE
- WATER
- BROMPHENIRAMINE MALEATE
- BROMPHENIRAMINE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PSEUDOEPHEDRINE HYDROCHLORIDE
- PSEUDOEPHEDRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 45737-203 | 45737-203-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| SUCROSE | C151H8M554 | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| WATER | 059QF0KO0R | IACT |
| BROMPHENIRAMINE MALEATE | IXA7C9ZN03 | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 6V9V2RYJ8N | ACTIB |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IRRIGATION | 2 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SUSPENSION / ORAL | 840 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SOLUTION / ORAL | 315 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | ELIXIR / ORAL | 800 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | JELLY / NASAL | 250 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TOPICAL | 4522 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM / VAGINAL | 22 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM / TOPICAL | 3000 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 0.4 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SPRAY / NASAL | 9 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / RECTAL | 3315 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, METERED / RECTAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SPRAY / NASAL | 0.2 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LIQUID / INTRAVENOUS | 0.2 %w/v | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, DELAYED RELEASE / ORAL | 955 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION / ORAL | 48209 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / INTRAVENOUS | 0.02 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER / ORAL | NA | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 119.12 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRA-ARTICULAR | 0.24 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TAMPON / VAGINAL | 62.1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | PASTE, DENTIFRICE / DENTAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM / BUCCAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / SUBCUTANEOUS | 0.16 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SHAMPOO / TOPICAL | 0.15 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CONCENTRATE / ORAL | 7000 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE, EXTENDED RELEASE / ORAL | 0.22 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / NASAL | 26 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION / INTRAVENOUS | 1950 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / AURICULAR (OTIC) | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM, AUGMENTED / TOPICAL | 8 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / INTRAMUSCULAR | 45 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRAMUSCULAR | 6 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET / ORAL | 914 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TROCHE / ORAL | 12 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SYSTEM / TOPICAL | 21 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CAPSULE / ORAL | 7 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERIDURAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / TOPICAL | 0.16 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LOTION / TOPICAL | 0.85 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | PASTILLE / ORAL | 426 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRABURSAL | ADJ PH | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER, FOR SUSPENSION / ORAL | 40017 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LIQUID / ORAL | 114 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SYRUP / ORAL | 40 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / OPHTHALMIC | 1.5 %w/v | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTION, EMULSION / INTRAVENOUS | 970 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTABLE, LIPOSOMAL / INTRAVENOUS | 7560 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SWAB / TOPICAL | 0.05 %w/w |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 29bbe8fc-74ee-280e-e063-6394a90a6799 | 9eb28921-8917-4c82-9994-853e36c74431 | 2024-12-20 | Warnings | 29bbe8fc-74ee-280e-e063-6394a90a6799 9eb28921-8917-4c82-9994-853e36c74431 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
