Daytime Cold and Flu
- Manufacturer
- KROGER COMPANY | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
- Effective date
- 2025-05-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:01:39
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
INDICATIONS & USAGE SECTION
Uses
- for the temporary relief of the following cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- nasal congestion
- cough
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
- temporarily reduces fever
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 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.
- if you have ever had an allergic reaction to this product or any of its ingredients.
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 an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
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 exceed recommended dose
OTC - STOP USE SECTION
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion or cough gets worse or lasts more than 7 days
- 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.
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.
DOSAGE & ADMINISTRATION SECTION
Directions
- do not take more than directed. (see overdose warning)
| adults and children 12 years and over |
|
| children under 12 years | ask a doctor |
OTHER SAFETY INFORMATION
Other information
- each caplet contains: sodium 3 mg
- store at room temperature, between 20º - 25ºC (68º - 77ºF), and avoid excessive heat and humidity
INACTIVE INGREDIENT SECTION
Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, crospovidone, D&C yellow no. 10 al. lake, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, talc, titanium dioxide, triacetin
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 |
|---|---|---|---|
| 1110988 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 2 |
| 1110988 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 2 |
| 1110988 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 2 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41226-675-24 | Daytime Cold and Flu | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 2 | |
| 41226-675-24 | Daytime Cold and Flu | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | 2 |
Products#
Every source-derived product name is available through these pages.
- Daytime Cold and Flu
- Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
- SILICON DIOXIDE
- CROSPOVIDONE
- TITANIUM DIOXIDE
- TRIACETIN
- CROSCARMELLOSE SODIUM
- D&C YELLOW NO. 10 ALUMINUM LAKE
- MAGNESIUM STEARATE
- POVIDONE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ACETAMINOPHEN
- HYPROMELLOSE, UNSPECIFIED
- MICROCRYSTALLINE CELLULOSE
- TALC
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 41226-675 | 41226-675-24 |
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 |
|---|---|---|---|---|---|---|
| 47b26bfd-f698-c63f-e063-6394a90afd40 | 30d4a6c6-895e-3741-e063-6294a90ab192 | 2026-01-06 | Warnings | 30d4a6c6-895e-3741-e063-6294a90ab192 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
