DAYTIME SEVERE COLD AND FLU
- Manufacturer
- KROGER COMPANY | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LTD
- Effective date
- 2025-02-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:55:22
Label at a glance#
ProductDAYTIME SEVERE COLD AND FLU
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure9 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each softgel)
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
temporarily relieves common cold/flu symptoms:
- nasal congestion
- sinus congestion & pressure
- cough due to minor throat & bronchial irritation
- headache
- fever
- sore throat
- reduces swelling of the nasal passages
temporarily restores freer breathing through the nose
promotes nasal and/or sinus drainage
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 8 softgels in 24 hrs, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily 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, chronic bronchitis or emphysema
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 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.
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
take only as directed
do not exceed 8 softgels per 24 hrs
- adults & children 12 yrs & over: 2 softgels with water every 4 hrs
- children 4 to under 12 yrs: ask a doctor
- children under 4 yrs: do not use
INACTIVE INGREDIENT SECTION
FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
OTHER SAFETY INFORMATION
Other information
- do not exceed 25°C
OTC - QUESTIONS SECTION
Questions or comments? Call 1-877-290-4008
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1656815 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 4 |
| 1656815 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 4 |
| 1656815 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule | SY | 4 |
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#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 41226-625-16 | 2025-02-14 | C162847 | 48780-1 | 2cef2736-a72b-d83d-e063-dadaa90ab31f | 625T KROGER 41226-625 MAX STRENGTH DAYTIME SEVERE COLD AND FLU |
| 41226-625-24 | 2025-02-14 | C162847 | 48780-1 | 2cef2736-a72b-d83d-e063-dadaa90ab31f | 625T KROGER 41226-625 MAX STRENGTH DAYTIME SEVERE COLD AND FLU |
| 41226-625-16 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-a72b-d83d-e063-dadaa90ab31f | 625T KROGER 41226-625 MAX STRENGTH DAYTIME SEVERE COLD AND FLU |
| 41226-625-24 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-a72b-d83d-e063-dadaa90ab31f | 625T KROGER 41226-625 MAX STRENGTH DAYTIME SEVERE COLD AND FLU |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 41226-625-24 | DAYTIME SEVERE COLD AND FLU | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 4 | |
| 41226-625-24 | DAYTIME SEVERE COLD AND FLU | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 41226-625 | DAYTIME SEVERE COLD AND FLU (ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN) CAPSULE, LIQUID FILLED [KROGER COMPANY] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250216_9bb7aaf0-6698-9a5c-e053-2a95a90a097c.zip |
Products#
Every source-derived product name is available through these pages.
- DAYTIME SEVERE COLD AND FLU
- ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN
- GLYCERIN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- GUAIFENESIN
- ACETAMINOPHEN
- SHELLAC
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- TITANIUM DIOXIDE
- PROPYLENE GLYCOL
- WATER
- SORBITOL
- FD&C BLUE NO. 1
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- FD&C RED NO. 40
- GELATIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 41226-625 | 41226-625-24 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| SHELLAC | 46N107B71O | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GELATIN | 2G86QN327L | 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 |
|---|---|---|---|---|---|---|
| DAYTIME SEVERE COLD AND FLU | ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN | KROGER COMPANY | 9bb7aaf0-6698-9a5c-e053-2a95a90a097c | 2025-02-14 | Warnings | 41226-625-24 41226-625 41226062524 2e141369-9e32-7624-e063-6294a90a25f9 9bb7aaf0-6698-9a5c-e053-2a95a90a097c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.