Indications and uses
• temporarily relieves common cold/flu symptoms: • cough due to minor throat and bronchial irritation • sore throat • headache • minor aches and pains • fever
Topcare DayTime Cold and Flu Relief
- Manufacturer
- Topco Associates LLC
- Effective date
- 2025-07-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 01:07:27
Label at a glance#
ProductTopcare DayTime Cold and Flu Relief
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure9 sections
Dosage and administration
• take only as directed – see Overdose warning • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 6 to under 12 yrs 15 mL every 4 hrs children 4 to under 6 yrs ask a doctor children under 4 yrs do not use
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each 15 mL)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Uses
- temporarily relieves common cold/flu symptoms:
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches and pains
- fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
Stop use and ask a doctor if
- pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- take only as directed – see Overdose warning
- only use the dose cup provided
- do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over | 30 mL every 4 hrs |
children 6 to under 12 yrs | 15 mL every 4 hrs |
children 4 to under 6 yrs | ask a doctor |
children under 4 yrs | do not use |
Other information
- each 15 mL contains: sodium 12 mg
- store at 20-25°C (68-77°F)
Inactive ingredients
anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum
Questions?
1-888-423-0139
Package/Label Principal Display Panel
TopCare® health
COMPARE TO VICKS® DAYQUIL® ACTIVE INGREDIENTS
MULTI-SYMPTOM RELIEF
DayTime Cold & Flu Relief
PAIN RELIEVER-FEVER REDUCER – ACETAMINOPHEN
COUGH SUPPRESSANT – DEXTROMETHORPHAN HBr
● Headache, Fever, Sore Throat, Minor Aches & Pains
● Cough
Alcohol Free
Antihistamine Free
Non-Drowsy
12 FL OZ (355 mL)
ELDERBERRY FLAVORED
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2604561 | acetaminophen 650 MG / dextromethorphan HBr 20 MG in 30 mL Oral Solution | PSN | 3 |
| 2604561 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral Solution | SCD | 3 |
| 2604561 | acetaminophen 325 MG / dextromethorphan HBr 10 MG per 15 ML Oral Solution | SY | 3 |
| 2604561 | acetaminophen 650 MG / dextromethorphan HBr 20 MG per 30 ML Oral Solution | SY | 3 |
| 2604561 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral Solution | SY | 3 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76162-483-40 | Topcare DayTime Cold and Flu Relief | 355 mL in 1 BOTTLE | SOLUTION | 355 | 3 |
Products#
Every source-derived product name is available through these pages.
- Topcare DayTime Cold and Flu Relief
- acetaminophen, dextromethorphan hydrobromide
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- ANHYDROUS CITRIC ACID
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- GLYCERIN
- PROPYLENE GLYCOL
- WATER
- SACCHARIN SODIUM
- SODIUM BENZOATE
- SODIUM CITRATE, UNSPECIFIED FORM
- SORBITOL SOLUTION
- SUCRALOSE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76162-483 | 76162-483-40 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CITRATE, UNSPECIFIED FORM | 1Q73Q2JULR | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| XANTHAN GUM | TTV12P4NEE | 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 |
|---|---|---|---|---|---|---|
| Topcare DayTime NiteTime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Topco Associates LLC | 560fb22b-391f-4d7b-a6fd-38d577d404b0 | 2025-09-23 | Warnings | 76162-483-40 76162048340 |
| Topcare DayTime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Topco Associates LLC | bb9663e3-fd11-4e72-bf85-fee4841b795f | 2025-07-15 | Warnings | 76162-483-40 76162-483 76162048340 c52c261b-a175-4ef6-aefd-42ecbbc34145 bb9663e3-fd11-4e72-bf85-fee4841b795f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.