• For the temporary relief of runny nose, sneezing, itching of the nose or throat and itchy, watery eyes due to hay fever. • Temporarily relieves cough due to minor throat and bronchial irritation occurring with the common cold. • Temporarily restores freer breathing through the nose.
• Do not exceed 6 doses in 24 hours. Adults and children 12 years of age and older 2 teaspoonfuls (10 mL) every 4 hours. Children 6 to under 12 years of age 1 teaspoonful (5 mL) every 4 hours. Children 2 to under 6 years of age Ask a doctor.
• Tamper evident feature: Do not use if inner seal is torn, broken or missing. • Store at controlled room temperature 15-30⁰C(59-86⁰F). • Avoid excessive heat or humidity.
www.kramernovis.comChlorpheniramine Maleate, 2 mg
Dextromethorphan HBr, 10 mg
Phenylephrine HCl, 5 mg
Antihistamine
Cough suppressant
Nasal decongestant
• For the temporary relief of runny nose, sneezing, itching of the nose or throat and itchy, watery eyes due to hay fever.
• Temporarily relieves cough due to minor throat and bronchial irritation occurring with the common cold.
• Temporarily restores freer breathing through the nose.
Do not use • to sedate a child or to make a child sleepy.
• If you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression, psychiatric or emotional condition) or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a 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 • difficulty in urination due to enlargement of the prostate gland • cough that occurs with too much phlegm (mucus) • breathing problems or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis 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• drowsiness may occur • avoid alcoholic beverages • alcohol, sedatives and tranquilizers may increase the drowsiness effect • use caution when driving a motor vehicle or operating machinery.
Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • excitability occurs, especially in children • symptoms do not improve within 7 days or are accompanied by fever • cough persists for more than 1 week tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.
• Do not exceed 6 doses in 24 hours.
| Adults and children 12 years of age and older | 2 teaspoonfuls (10 mL) every 4 hours. |
| Children 6 to under 12 years of age | 1 teaspoonful (5 mL) every 4 hours. |
| Children 2 to under 6 years of age | Ask a doctor. |
• Tamper evident feature: Do not use if inner seal is torn, broken or missing.
• Store at controlled room temperature 15-30⁰C(59-86⁰F).
• Avoid excessive heat or humidity.
citric acid, flavor, FD&C #40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucrose.
call weekdays from 8 AM to 4 PM AST at 1.787.767.2072
ANTIHISTAMINE
Chlorpheniramine Maleate
COUGH SUPPRESSANT
Dextromethorphan Hbr
NASAL DECONGESTANT
Phenylephrine Hcl
Cherry Flavor
Kramer Novis
Pharmaceuticals within reach of patients
Manufactured in the USA for Kramer Novis
San Juan, PR 00917www.kramernovis.com
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1363752 | chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 5 mL Oral Solution | PSN | 7 |
| 1363752 | chlorpheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution | SCD | 7 |
| 1363752 | chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 5 ML Oral Solution | SY | 7 |
| Class | Version | Type | Effective |
|---|---|---|---|
| CHLORPHENIRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| 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 | 0352083650161 | GTIN-13: 0352083650161 EAN-13: 0352083650161 GTIN-12: 352083650161 UPC-A: 352083650161 GTIN storage (14 digits): 00352083650161 | 52083650-2.jpg |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52083-650-16 | 2025-11-14 | C162847 | 48780-1 | 2cef2736-5da3-d83d-e063-dadaa90ab31f | GENCONTUSS |
| 52083-650-16 | 2025-11-14 | C162847 | 48780-1 | 2cef2736-5da3-d83d-e063-dadaa90ab31f | GENCONTUSS ® |
| 52083-650-16 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-5da3-d83d-e063-dadaa90ab31f | GENCONTUSS |
| 52083-650-16 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-5da3-d83d-e063-dadaa90ab31f | GENCONTUSS ® |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52083-650-16 | GENCONTUSS | 473 mL in 1 BOTTLE, PLASTIC | SOLUTION | 473 | 7 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52083-650-16 | ML - Milliliter | 52083-650 | 06ae7d11-09ed-4531-ad88-041ec9f515c2 | 1 | 2015-07-20 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| CHLORPHENIRAMINE MALEATE | ACTIVE INGREDIENT | V1Q0O9OJ9Z | 1 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| CHLORPHENIRAMINE | ACTIVE MOIETY | 3U6IO1965U | 1 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 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 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 52083-650 | 52083-650-16 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CITRATE, UNSPECIFIED FORM | 1Q73Q2JULR | IACT |
| SUCROSE | C151H8M554 | IACT |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 6 | 2025-11-13 | monthly-update | 2026-06-03 17:40:07 |
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 |
|---|---|---|---|---|---|---|
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / ORAL | 100 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / ORAL | 346 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / ORAL | 446 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SOLUTION / ORAL | 800 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / ORAL | 446 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SOLUTION / ORAL | 800 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / ORAL | 100 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / ORAL | 346 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 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 |
|---|---|---|---|---|---|---|
| GENCONTUSS | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | KRAMER NOVIS | 69d16d25-b09b-430e-8e01-0962d840dc21 | 2025-12-04 | Warnings | 52083-650-16 52083-650 52083065016 8a52f9ca-43f9-4f88-ae67-2ee6e1541d51 69d16d25-b09b-430e-8e01-0962d840dc21 |
Adverse event summaries are temporarily unavailable. Other product information remains available.