Indications and uses
temporarily relieves these symptoms of the common cold, hay fever or other upper respiratory allergies: cough runny nose nasal congestion sneezing itching of the nose or throat itchy, watery eyes
temporarily relieves these symptoms of the common cold, hay fever or other upper respiratory allergies: cough runny nose nasal congestion sneezing itching of the nose or throat itchy, watery eyes
dose may be repeated every 6 hours. do not exceed 4 doses in a 24-hour period use enclosed dosage cup only. Do not use any other device. AGE DOSE Children 6 to 11 years 2 TSP Children under 6 years Do not use
store at 20°-25° C (68°-77° F)
Drug Facts
| Active ingredients (in each 2 TSP (10 mL)) | Purposes |
|---|---|
| Chlorpheniramine maleate, USP 2 mg | Antihistamine |
| Dextromethorphan HBr, USP 10 mg | Cough suppressant |
| Pseudoephedrine HCl, USP 30 mg | Nasal decongestant |
temporarily relieves these symptoms of the common cold, hay fever or other upper respiratory allergies:
Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Ask a doctor before use if child has
Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers
Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away.
| AGE | DOSE |
|---|---|
| Children 6 to 11 years | 2 TSP |
| Children under 6 years | Do not use |
store at 20°-25° C (68°-77° F)
artificial cherry flavor, citric acid, FD&C red #40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution
1-800-645-2158
Distributed by:
Rugby Laboratories
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0536-2310-97 | ML - Milliliter | 0536-2310 | 99d52e82-2cf1-4739-80af-abeccc1c2858 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Chlorpheniramine | ACTIVE INGREDIENT | 3U6IO1965U | 1 | |
| Dextromethorphan Hydrobromide | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| Pseudoephedrine Hydrochloride | ACTIVE INGREDIENT | 6V9V2RYJ8N | 1 | |
| Chlorpheniramine | ACTIVE MOIETY | 3U6IO1965U | 1 | |
| Dextromethorphan | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| Pseudoephedrine | ACTIVE MOIETY | 7CUC9DDI9F | 1 | |
| Anhydrous Trisodium Citrate | INACTIVE INGREDIENT | RS7A450LGA | 1 | |
| Cherry | INACTIVE INGREDIENT | BUC5I9595W | 1 | |
| Citric Acid Monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| FD&C Red no. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| Sodium Benzoate | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0536-2310 | 0536-2310-97 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| WATER | 059QF0KO0R | IACT |
| CHERRY | BUC5I9595W | IACT |
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 6V9V2RYJ8N | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / TOPICAL | 8 %w/w | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SOLUTION / ORAL | 315 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CAPSULE, EXTENDED RELEASE / ORAL | 101 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | GEL / DENTAL | 0.08 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | JELLY / TOPICAL | 20 %w/w | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRALESIONAL | ADJ PH | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE / ORAL | 1072 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| Anhydrous Trisodium Citrate | ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | INJECTION / INTRAMUSCULAR | 792 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, EXTENDED RELEASE / ORAL | 45 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | DROPS / ORAL | 300 mg/1ml | ||
| Anhydrous Trisodium Citrate | ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | POWDER, FOR SOLUTION / ORAL | 48 mg/5ml | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRABURSAL | ADJ PH | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / RECTAL | 27 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION, CONCENTRATE / INTRAVENOUS | NA | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / SUBLINGUAL | 36 mg | ||
| FD&C Red no. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION / ORAL | 100 mg/5ml | ||
| Cherry | CHERRY | BUC5I9595W | TABLET / ORAL | 0.45 mg | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAVENOUS | 16624 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SPRAY, METERED / NASAL | 13 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRAMUSCULAR | 28 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | CREAM / TOPICAL | 0.2 %w/w | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION, CONCENTRATE / IRRIGATION | 1 mg | ||
| FD&C Red no. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, FILM COATED / ORAL | 2.5 mg | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / OPHTHALMIC | 1 %w/v | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION / OPHTHALMIC | ADJ PH | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / OPHTHALMIC | 0.03 %w/v | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYRUP / ORAL | 722 mg/5ml | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / NASAL | 5 mg | ||
| Anhydrous Trisodium Citrate | ANHYDROUS TRISODIUM CITRATE | RS7A450LGA | SOLUTION / TOPICAL | 0.1 %w/v | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | INJECTION, SOLUTION / INTRAMUSCULAR | 4.8 %w/v | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO / TOPICAL | 8 %w/w | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRAPLEURAL | ADJ PH | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYSTEM / IONTOPHORESIS | 0.2 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | SPONGE / TOPICAL | NA | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 38 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER / ORAL | 840 mg | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / DENTAL | 2 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / SUBCUTANEOUS | 450 mg | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 63.4 %w/v | ||
| FD&C Red no. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, LIQUID FILLED / ORAL | 1 mg | ||
| FD&C Red no. 40 | FD&C RED NO. 40 | WZB9127XOA | GUM, CHEWING / BUCCAL | 48 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, FILM COATED / ORAL | 42 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET / ORAL | 64 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / TOPICAL | 0.1 %w/v | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CAPSULE / ORAL | 238 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | PASTE / DENTAL | 0.5 %w/w | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | PASTE / ORAL | 28 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 608 mg | ||
| Propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / RECTAL | 1214 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v |
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 |
|---|---|---|---|---|---|---|
| 93640944-8e90-d456-e053-2995a90ac9fe | 63fdf19e-f467-4873-8cbf-da2e5e2cdc0b | 2019-09-25 | Warnings | 93640944-8e90-d456-e053-2995a90ac9fe 63fdf19e-f467-4873-8cbf-da2e5e2cdc0b |
Adverse event summaries are temporarily unavailable. Other product information remains available.