Indications and uses
temporarily relieves itchy, watery eyes runny nose itchy nose or throat sneezing nasal and sinus congestion as may occur with a cold
temporarily relieves itchy, watery eyes runny nose itchy nose or throat sneezing nasal and sinus congestion as may occur with a cold
may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor. to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age. specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device. Age Dose children under 4 years of age do not use children 4 to...
each teaspoonful contains: sodium 3 mg store at controlled room temperature 20°-25°C (68°-77°F)
ALLERGY & STUFFY NOSE
Drug Facts
| Active ingredients (in each 5 mL, 1 teaspoonful) | Purposes |
|---|---|
| Chlorpheniramine maleate 1 mg | Antihistamine |
| Phenylephrine HCl 2.5 mg | Nasal decongestant |
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 under 4 years of age | do not use |
| children 4 to under 6 years of age | do not use unless directed by a doctor |
| children 6 to under 12 years of age | 1-2 tsp. (5-10 mL) |
artificial flavor, benzoic acid, citric acid, disodium EDTA, FD&C yellow #6, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.
877-434-2036
CHILDREN'S
ACCUDIAL
ROTATING DOSING LABEL
Allergy
& Stuffy Nose
ACCURATE DOSING
BY WEIGHT
Chlorpheniramine maleate
(Antihistamine)
Phenylephrine HCl
(Nasal Decongestant)
Itchy, Watery Eyes
Runny Nose
Stuffy Nose
Sneezing
For Ages 6 to under 12
Compares to
Children's Triaminic®
Cold & Allergy.
ORANGE
FLAVOR
4 FL. OZ.
(118 mL)
NDC 45014-141-04

| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1429345 | chlorpheniramine maleate 1 MG / phenylephrine hydrochloride 2.5 MG in 5 mL Oral Solution | PSN | 1 |
| 1429345 | chlorpheniramine maleate 0.2 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 1 |
| 1429345 | chlorpheniramine maleate 1 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| CHLORPHENIRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 45014-141-04 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-ccc6-621f-e053-dbdaa90a74ad | Children's ACCUDIAL |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 45014-141-04 | Allergy and Stuffy Nose | 118 mL in 1 BOTTLE | LIQUID | 118 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Chlorpheniramine Maleate | ACTIVE INGREDIENT | V1Q0O9OJ9Z | 1 | |
| Phenylephrine Hydrochloride | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| Chlorpheniramine | ACTIVE MOIETY | 3U6IO1965U | 1 | |
| Phenylephrine | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| Benzoic Acid | INACTIVE INGREDIENT | 8SKN0B0MIM | 1 | |
| Citric Acid Monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| Edetate Disodium | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| Orange | INACTIVE INGREDIENT | 5EVU04N5QU | 1 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| Saccharin Sodium | INACTIVE INGREDIENT | SB8ZUX40TY | 1 | |
| Sodium Citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | 1 | |
| Sorbitol | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 45014-141 | 45014-141-04 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Chlorpheniramine Maleate | V1Q0O9OJ9Z | ACTIB |
| Phenylephrine Hydrochloride | 04JA59TNSJ | ACTIB |
| Orange | 5EVU04N5QU | IACT |
| Benzoic Acid | 8SKN0B0MIM | IACT |
| Citric Acid Monohydrate | 2968PHW8QP | IACT |
| Edetate Disodium | 7FLD91C86K | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| Propylene Glycol | 6DC9Q167V3 | IACT |
| Water | 059QF0KO0R | IACT |
| Sodium Citrate | 1Q73Q2JULR | IACT |
| Saccharin Sodium | SB8ZUX40TY | IACT |
| Sorbitol | 506T60A25R | 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 |
|---|---|---|---|---|---|---|
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / PERIDURAL | NA | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAMUSCULAR | 7459 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | DROPS / OPHTHALMIC | 0.05 %w/v | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, EXTENDED RELEASE / ORAL | 45 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER / ORAL | 840 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | TABLET, ORALLY DISINTEGRATING / ORAL | 3 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET / ORAL | 914 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SOLUTION / TOPICAL | NA | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / TOPICAL | 1800 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / OPHTHALMIC | 1.5 %w/v | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SPRAY, METERED / NASAL | 2 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / RESPIRATORY (INHALATION) | 10 %w/w | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / AURICULAR (OTIC) | 0.01 %w/v | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / RECTAL | 0.6 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / BUCCAL | NA | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | DOUCHE / VAGINAL | 0.07 %w/w | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / INTRAVENOUS | 7 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | TABLET, CHEWABLE / ORAL | 1 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION, CONCENTRATE / IRRIGATION | 1 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, FOR SUSPENSION / ORAL | 6 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, DELAYED RELEASE / ORAL | 0.02 mg | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | TABLET, COATED / ORAL | NA | ||
| Sorbitol | SORBITOL | 506T60A25R | TABLET / SUBLINGUAL | 50.5 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LIQUID / INTRAVENOUS | 0.2 %w/v | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / TOPICAL | 1 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / AURICULAR (OTIC) | 0.01 %w/v | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INHALANT / RESPIRATORY (INHALATION) | NA | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | AEROSOL, FOAM / TOPICAL | 1 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / ORAL | 2590 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CONCENTRATE / ORAL | 7000 mg | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | INJECTION / INTRAMUSCULAR | 5 %w/v | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SPRAY / NASAL | 9 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYSTEM / IONTOPHORESIS | 0.2 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / INTRAOCULAR | 1 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | CREAM / VAGINAL | 10 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / INTRAVENOUS | 396 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / TOPICAL | 0.75 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, SOLUBLE / BUCCAL | 5 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL / TOPICAL | 19.2 %w/w | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / ORAL | 665 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / INTRAMUSCULAR | 26 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVASCULAR | 0.48 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / EPIDURAL | 0.02 %w/v | ||
| Sorbitol | SORBITOL | 506T60A25R | TABLET, ORALLY DISINTEGRATING / ORAL | 7 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | ELIXIR / ORAL | 100 mg/5ml | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | EMULSION / OPHTHALMIC | 0.3 %w/v | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | CAPSULE / ORAL | 5 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / AURICULAR (OTIC) | 10 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM / BUCCAL | 1.48 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM, AUGMENTED / TOPICAL | 8 %w/w | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SHAMPOO, SUSPENSION / TOPICAL | 0.25 %w/v | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | GEL / TOPICAL | 1 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | SOLUTION / RECTAL | 665 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | OINTMENT / TOPICAL | NA | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | SUSPENSION / ORAL | 15 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | DROPS / ORAL | NA |
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 |
|---|---|---|---|---|---|---|
| bd6d673a-27d7-4fa7-9d0f-62a89882ea6e | 96ebdeec-9f97-44a6-adce-b2e100d3168e | 2009-11-11 | Warnings | bd6d673a-27d7-4fa7-9d0f-62a89882ea6e 96ebdeec-9f97-44a6-adce-b2e100d3168e |
Adverse event summaries are temporarily unavailable. Other product information remains available.