Indications and uses
Temporarily relieves nasal and sinus congestion cough due to minor throat and bronchial irritation as may occur with a cold.
Daytime Cough and Cold
- Manufacturer
- Accudial Pharmaceutical, Inc. | Bio-Pharm, Inc.
- Effective date
- 2013-02-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:34:27
Label at a glance#
ProductDaytime Cough and Cold
Active ingredientDextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Label structure10 sections
Dosage and administration
may be given every 4 hours do not use more than 6 times in 24 hours use only enclosed dosing cup to dose this product. Do not use any other dosing device.
Storage and handling
each teaspoon contains: sodium 2 mg store between 20°-25°C (68°-77°F) tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredient (in each 5 mL = 1 teaspoon) | Purpose |
|---|---|
| Dextromethorphan HBr, USP 5 mg | Cough suppressant |
| Phenylephrine HCl, USP 2.5 mg | Nasal decongestant |
Uses
Temporarily relieves
- nasal and sinus congestion
- cough due to minor throat and bronchial irritation as may occur with a cold.
Warnings
OTC - DO NOT USE SECTION
Do not use in a child under 4 years of age
- 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 the child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if the child has heart disease
- high blood pressure
- thyroid disease
- diabetes
- cough that occurs with too much phlegm (mucus)
- chronic cough that lasts, or as occurs with asthma.
When using this product
- do not exceed recommended dosage.
OTC - STOP USE SECTION
Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs.
- symptoms do not improve within 7 days or occur with a fever.
- cough persists for more than 7 days, comes back, or occurs with a fever, rash, or persistent headache. These could be signs of a serious condition.
OTC - ASK DOCTOR/PHARMACIST SECTION
Consult your pharmacist or health care provider for any appropriate, additional dosage delivery device necessary for use when a physician recommends a dose that is different than the doses that appear on the dosage delivery device that accompanies this product.
| Age (yr) | Dose (TSP) |
|---|---|
| under 4 yrs. | ask a doctor |
| 4 to under 6 | 1 TSP |
| 6 to under 12 | 2 TSP |
| or as directed by a doctor | |
| TSP = teaspoon | |
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Overdose warning
Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms.
Other information
- each teaspoon contains: sodium 2 mg
- store between 20°-25°C (68°-77°F)
- tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.
Directions
- may be given every 4 hours
- do not use more than 6 times in 24 hours
- use only enclosed dosing cup to dose this product. Do not use any other dosing device.
Questions?
877-434-2036
Inactive ingredients
artificial flavor, benzoic acid, citric acid, EDTA disodium dihydrate, FD&C red #40, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.
SPL UNCLASSIFIED SECTION
Distributed by: AccuDial® Pharmaceutical, Inc.
Palm Beach Gardens, FL 33408
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
ACCUDIAL®
Children's
Daytime
Cough and Cold
Dextromethorphan HBr (Cough Suppressant)
Phenylephrine HCl (Nasal Decongestant)
Relieves Cough • Stuffy Nose
Earth-Friendly
Package!
For Ages 4 yrs to under 12 yrs
Tamper Evident
Compares to Children's Triaminic ®
Day Time Cold & Cough
CHERRY
FLAVOR
NDC 45014-158-04
4 FL. OZ. (118 mL)
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1544873 | dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution | PSN | 1 |
| 1544873 | dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 1 |
| 1544873 | dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Syrup | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 45014-158-04 | 2019-11-27 | C162847 | 48780-1 | 9855d018-ec72-cd31-e053-dbdaa90ab51a | Daytime Cough & Cold |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 45014-158-04 | Daytime Cough and Cold | 118 mL in 1 BOTTLE | SOLUTION | 118 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 45014-158 | DAYTIME COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACCUDIAL PHARMACEUTICAL, INC.] | 1 | Legacy NDC, 1 package rows | 20130209_e9e021cf-b8eb-4309-bf0b-a24334ba278e.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Dextromethorphan Hydrobromide | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| Phenylephrine Hydrochloride | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| Dextromethorphan | ACTIVE MOIETY | 7355X3ROTS | 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 Red No. 40 | INACTIVE INGREDIENT | WZB9127XOA | 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 |
Products#
Every source-derived product name is available through these pages.
- Daytime Cough and Cold
- Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride
- Dextromethorphan Hydrobromide
- Dextromethorphan
- Phenylephrine Hydrochloride
- Phenylephrine
- Benzoic Acid
- Citric Acid Monohydrate
- Edetate Disodium
- FD&C Red No. 40
- Propylene Glycol
- Water
- Sodium Citrate
- Saccharin Sodium
- Sorbitol
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 45014-158 | 45014-158-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Dextromethorphan Hydrobromide | 9D2RTI9KYH | ACTIB |
| Phenylephrine Hydrochloride | 04JA59TNSJ | ACTIB |
| Benzoic Acid | 8SKN0B0MIM | IACT |
| Citric Acid Monohydrate | 2968PHW8QP | IACT |
| Edetate Disodium | 7FLD91C86K | IACT |
| FD&C Red No. 40 | WZB9127XOA | IACT |
| Propylene Glycol | 6DC9Q167V3 | IACT |
| Water | 059QF0KO0R | IACT |
| Sodium Citrate | 1Q73Q2JULR | IACT |
| Saccharin Sodium | SB8ZUX40TY | IACT |
| Sorbitol | 506T60A25R | IACT |
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 |
|---|---|---|---|---|---|---|
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | CONCENTRATE / ORAL | 20 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / SUBCUTANEOUS | 1.4 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAMUSCULAR | 7459 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CREAM / TOPICAL | 4 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | CAPSULE / ORAL | 24 mg | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | SUSPENSION / RECTAL | 0.1 %w/w | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION/ DROPS / OPHTHALMIC | 0.05 %w/v | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CAPSULE / ORAL | 238 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | CREAM / TOPICAL | 14 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | CAPSULE / ORAL | 5 mg | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | FILM / BUCCAL | 3 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / TOPICAL | 17 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYRUP / ORAL | 722 mg/5ml | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / INTRAMUSCULAR | 1 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRACARDIAC | 1.05 %w/v | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, CHEWABLE / ORAL | 40 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / NASAL | 100 mg/100ml | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | SUPPOSITORY / VAGINAL | 2 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED / ORAL | NA | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / RESPIRATORY (INHALATION) | 25 %w/w | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | DROPS / ORAL | NA | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAMUSCULAR | 10 %w/v | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | SYRUP / ORAL | 24 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE / ORAL | 16 mg | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | AEROSOL, FOAM / TOPICAL | 1 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION, EXTENDED RELEASE / ORAL | 1000 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | DOUCHE / VAGINAL | 0.07 %w/w | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, LIQUID FILLED / ORAL | 1 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | SOLUTION / ORAL | 29268 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / OPHTHALMIC | 1 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 63.4 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION / TOPICAL | 3392 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOAP / TOPICAL | 0.5 %w/w | ||
| Sorbitol | SORBITOL | 506T60A25R | CONCENTRATE / ORAL | 600 mg/1ml | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRACARDIAC | 2 mg | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | SOLUTION / ORAL | 100 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYSTEM / IONTOPHORESIS | 0.2 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | TABLET, FILM COATED / ORAL | 4 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / SOFT TISSUE | ADJ PH | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | DROPS / ORAL | NA | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | INJECTION / INTRAVENOUS | 5 %w/v | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, COATED / ORAL | 0.1 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / AURICULAR (OTIC) | 0.2 %w/v | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION, CONCENTRATE / IRRIGATION | 1 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / AURICULAR (OTIC) | 0.1 %w/v | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | SOLUTION / IRRIGATION | 0.02 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TOPICAL | 4522 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | POWDER, FOR SUSPENSION / ORAL | 285 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SHAMPOO / TOPICAL | 1 %w/w | ||
| Sorbitol | SORBITOL | 506T60A25R | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 1.04 %w/v | ||
| Saccharin Sodium | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / RECTAL | 290 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | INJECTION, SOLUTION / INTRAVENOUS | 4050 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CONCENTRATE / ORAL | 7000 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / OPHTHALMIC | 0.06 %w/v | ||
| Benzoic Acid | BENZOIC ACID | 8SKN0B0MIM | TABLET, FILM COATED / ORAL | NA | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR | 1 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, EXTENDED RELEASE / ORAL | 2.22 mg | ||
| Citric Acid Monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION / ORAL | 269 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 0.4 mg |
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 |
|---|---|---|---|---|---|---|
| 97558c3c-84f5-4185-8462-a113bd2e3be8 | e9e021cf-b8eb-4309-bf0b-a24334ba278e | 2013-02-06 | Warnings | 97558c3c-84f5-4185-8462-a113bd2e3be8 e9e021cf-b8eb-4309-bf0b-a24334ba278e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.