Daytime Cold and Flu
- Manufacturer
- Grocery Outlet, Inc. | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
- Effective date
- 2026-03-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:51:20
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each 15 mL)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
INDICATIONS & USAGE SECTION
Usestemporarily relieves common cold/flu symptoms:
- nasal congestion
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches & pains
- fever
WARNINGS SECTION
Warnings
Liver warning:This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product
- child takes more than 4 doses (15 mL each) in 24 hrs, which is the maximum daily amount for this product
- 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.
OTC - DO NOT USE SECTION
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.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- a sodium-restricted diet
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
OTC - WHEN USING SECTION
When using this product, do not use more than directed.
OTC - STOP USE SECTION
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- pain, nasal congestion or cough get worse or last 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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions
- take only as directed
- 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 SAFETY INFORMATION
Other information
- each 15 mL contains: sodium 56 mg
- store at no greater than 25°C and do not refrigerate
INACTIVE INGREDIENT SECTION
Inactive ingredients anhydrous citric acid, FD&C yellow no. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sodium saccharin, sorbitol solution, sucralose, xanthan gum
OTC - QUESTIONS SECTION
Questions or comments?Call 1-800-632-6900
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 1 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 1 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 1 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 1 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | 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#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85828-772-01 | Daytime Cold and Flu | 354 mL in 1 BOTTLE | LIQUID | 354 | 1 |
Products#
Every source-derived product name is available through these pages.
- Daytime Cold and Flu
- Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine HCl
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SORBITOL SOLUTION
- SUCRALOSE
- ANHYDROUS CITRIC ACID
- GLYCERIN
- SODIUM CITRATE
- SACCHARIN SODIUM
- FD&C YELLOW NO. 6
- POLYETHYLENE GLYCOL, UNSPECIFIED
- XANTHAN GUM
- SODIUM CHLORIDE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- ACETAMINOPHEN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85828-772 | 85828-772-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL | Grocery Outlet, Inc. | 4d88180f-610c-d9ab-e063-6394a90a09f0 | 2026-03-21 | Warnings | 85828-772-01 85828-772 85828077201 4d88180f-610d-d9ab-e063-6394a90a09f0 4d88180f-610c-d9ab-e063-6394a90a09f0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
