• temporarily relieves: • runny nose • sneezing • itching of the nose or throat • itchy, watery eyes due to hay fever or other upper respiratory allergies • temporarily controls cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants • temporarily relieves nasal congestion due to hay fever or other upper respiratory allergies • temporarily restores freer breathing through ...
• do not take more than 6 doses in any 24-hour period. • mL = milliliter, tsp = teaspoon adults and children 12 years of age and over 5 mL (1 tsp) every 4 hours children 6 to under 12 years of age 2.5 mL (½ tsp) every 4 hours children under 6 years of age do not use
• tamper evident feature: do not use if security seal is torn, broken or missing. • store at controlled room temperature 15-30°C (59-86°F). • avoid excessive heat or humidity.
www.kramernovis.comBrompheniramine Maleate 4 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg
Antihistamine
Cough suppressant
Nasal decongestant
• temporarily relieves:
• runny nose • sneezing • itching of the nose or throat • itchy, watery eyes due to hay fever or other upper respiratory allergies
• temporarily controls cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants
• temporarily relieves nasal congestion due to hay fever or other upper respiratory allergies • temporarily restores freer breathing through the 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 • glaucoma • cough that occurs with too much phlegm (mucus) • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis • chronic cough that lasts such as occurs with smoking, asthma, or emphysema.
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
When using this product • do not exceed recommended dosage
• excitability may occur, especially in children • drowsiness may occur; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Use caution when driving a motor vehicle or operating machinery.
Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • new symptoms occur • symptoms do not get better within 7 days or are accompanied by fever • coughs lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of serious conditions.
If pregnant or breast-feeding, 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.
• do not take more than 6 doses in any 24-hour period.
• mL = milliliter, tsp = teaspoon
| adults and children 12 years of age and over | 5 mL (1 tsp) every 4 hours |
| children 6 to under 12 years of age | 2.5 mL (½ tsp) every 4 hours |
| children under 6 years of age | do not use |
• tamper evident feature: do not use if security seal is torn, broken or missing.
• store at controlled room temperature 15-30°C (59-86°F).
• avoid excessive heat or humidity.
citric acid, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sucralose.
You may also report serious side effects to this phone number.
Call weekdays from 8 AM to 4 PM AST
Brompheniramine Maleate
ANTIHISTAMINE
Dextromethorphan HBr
COUGH SUPPRESSANT
Phenylephrine HCl
NASAL DECONGESTANT
SUGAR AND ALCOHOL FREE
SACCHARINE FREE
DYE FREE
Compare to Tussi-Press®B
GRAPE FLAVOR
Kramer Novis
Pharmaceuticals within reach of patients
Manufactured for Kramer Novis
San Juan, PR 00917
Manufactured in the USA with imported ingredients
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1148155 | brompheniramine maleate 4 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG in 5 mL Oral Solution | PSN | 5 |
| 1148155 | brompheniramine maleate 0.8 MG/ML / dextromethorphan hydrobromide 4 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral Solution | SCD | 5 |
| 1148155 | brompheniramine maleate 4 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral Solution | SY | 5 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0352083637162 | GTIN-13: 0352083637162 EAN-13: 0352083637162 GTIN-12: 352083637162 UPC-A: 352083637162 GTIN storage (14 digits): 00352083637162 | 52083637-3.jpg |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52083-637-16 | 2025-12-10 | C162847 | 48780-1 | 2cef2736-65f4-d83d-e063-dadaa90ab31f | PRESGEN ® B |
| 52083-637-16 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-65f4-d83d-e063-dadaa90ab31f | PRESGEN ® B |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52083-637-16 | Presgen B | 480 mL in 1 BOTTLE | SYRUP | 480 | 5 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52083-637-16 | ML - Milliliter | 52083-637 | 7474eab9-a976-4e23-855d-88ff37beb750 | 1 | 2013-03-03 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BROMPHENIRAMINE MALEATE | ACTIVE INGREDIENT | IXA7C9ZN03 | 1 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| BROMPHENIRAMINE | ACTIVE MOIETY | H57G17P2FN | 1 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 52083-637 | 52083-637-16 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BROMPHENIRAMINE MALEATE | IXA7C9ZN03 | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
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 |
|---|---|---|---|---|---|---|
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SYRUP / ORAL | 80 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYRUP / ORAL | 722 mg/5ml | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYRUP / ORAL | 722 mg/5ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SYRUP / ORAL | 81 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SYRUP / ORAL | 81 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SYRUP / ORAL | 80 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SYRUP / ORAL | 40 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SYRUP / ORAL | 40 mg |
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 |
|---|---|---|---|---|---|---|
| Presgen B | DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | KRAMER NOVIS | 5befa829-32bd-4978-8a0e-1d6513ff37a4 | 2025-12-03 | Warnings | 52083-637-16 52083-637 52083063716 0e6e64a1-f9ee-47cb-8ee7-23800b7fb564 5befa829-32bd-4978-8a0e-1d6513ff37a4 |
Adverse event summaries are temporarily unavailable. Other product information remains available.