Indications and uses
temporarily relieves: nasal and sinus congestion cough due to minor throat and bronchial irritation as may occur with a cold
DayTime Cold and Cough
- Manufacturer
- P & L Development, LLC
- Effective date
- 2023-06-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:30:24
Label at a glance#
ProductDayTime Cold and Cough Childrens
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
do not take more than 6 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device keep dosing cup with product mL = milliliter shake well before using Age Dose children 6 to under 12 years of age 10 mL every 4 hours children 4 to under 6 years of age 5 mL every 4 hours children under 4 years of age do not use
Storage and handling
each 5 mL contains : sodium 2 mg store between 20-25°C (68-77°F). Do not refrigerate.
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each 5 mL)
Dextromethorphan HBr 5 mg
Phenylephrine HCl 2.5 mg
Purposes
Cough suppressant
Nasal decongestant
Uses
- temporarily relieves:
- nasal and sinus congestion
- cough due to minor throat and bronchial irritation as may occur with a cold
Warnings
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.
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.
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.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- mL = milliliter
- shake well before using
| Age | Dose |
| children 6 to under 12 years of age | 10 mL every 4 hours |
| children 4 to under 6 years of age | 5 mL every 4 hours |
| children under 4 years of age | do not use |
Other information
- each 5 mL contains: sodium 2 mg
- store between 20-25°C (68-77°F). Do not refrigerate.
Inactive ingredients
acesulfame potassium, alcohol, benzoic acid, citric acid, disodium EDTA, FD&C red #40, maltitol, flavor, propylene glycol, purified water, sodium citrate
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredients in Children's Triaminic® DayTime Cold & Cough*
Children's triacting daytime Cold & Cough
dextromethorphan HBr 5 mg Cough suppressant
phenylephrine HCl 2.5 mg Nasal decongestant
relieves:
- cough
- stuffy nose
for ages 4 to 11
alcohol 0.14 %
Cherry Flavor
FL OZ (mL)
*This product is not manufactured or distributed by GSK Consumer Healthcare, distributors of Children's Triaminic® DayTime Cold & Cough.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP BROKEN OR MISSING.
Manufactured by:
PL Developments
11865 S. Alameda St
Lynwood, CA 90262
Package Label
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49580-0378-4 | 2023-06-07 | C162847 | 48780-1 | f386c649-bf55-0266-e053-dadaa90a7c1a | Drug Facts |
| 49580-0378-4 | 2023-01-30 | C162847 | 48780-1 | f386c649-bf55-0266-e053-dadaa90a7c1a | Drug Facts |
Products#
Every source-derived product name is available through these pages.
- DayTime Cold and Cough Childrens
- Dextromethorphan HBr, Phenylephrine HCl
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ACESULFAME POTASSIUM
- ALCOHOL
- BENZOIC ACID
- ANHYDROUS CITRIC ACID
- EDETATE DISODIUM
- FD&C RED NO. 40
- MALTITOL
- PROPYLENE GLYCOL
- WATER
- TRISODIUM CITRATE DIHYDRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49580-0378 | 49580-0378-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| BENZOIC ACID | 8SKN0B0MIM | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| MALTITOL | D65DG142WK | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| TRISODIUM CITRATE DIHYDRATE | B22547B95K | IACT |
Source Document#
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 |
|---|---|---|---|---|---|---|
| 6254de61-36f7-4839-9100-cf3d61ba962f | 7d8ccd41-115f-4db7-a978-6775411c5f95 | 2023-06-07 | Warnings | 6254de61-36f7-4839-9100-cf3d61ba962f 7d8ccd41-115f-4db7-a978-6775411c5f95 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.