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
Daytime Cold and Flu Capsules (PE free)
- Manufacturer
- Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd
- Effective date
- 2025-12-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:28:53
Label at a glance#
ProductDaytime Cold and Flu
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN
Label structure10 sections
Dosage and administration
Take only as directed (see overdose warning) Do not take more than 4 doses in 24 hours. adults and children 12 years and over 2 softgels with water every 4 hours children 4 to under 12 years consult a doctor children under 4 years do not use
Storage and handling
Store at 15° - 30 °C (59°- 86 °F) Read all product information before using. Tamper evident: Do not use if carton is open or blister unit is broken.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active Ingredients (in each softgel)
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 you take
- more than 4 doses in 24 hours, which is the maximum daily amount for this product
- 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, lasts 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 as occurs with smoking, asthma, or emphysema
OTC - WHEN USING SECTION
When using this product do not exceed recommended dose.
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.
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 accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Prompt 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)
- Do not take more than 4 doses in 24 hours.
| adults and children 12 years and over | 2 softgels with water every 4 hours |
| children 4 to under 12 years | consult a doctor |
| children under 4 years | do not use |
Other information
- Store at 15° - 30 °C (59°- 86 °F)
- Read all product information before using.
- Tamper evident: Do not use if carton is open or blister unit is broken.
Inactive ingredients
FD&C Red # 40, FD&C Yellow # 6, Gelatin, Glycerin, Polyethylene Glycol 400, Povidone K12, Propylene Glycol, Purified water, Sorbitol Sorbitan Solution, White ink.
QUESTIONS OR COMMENTS?
Call toll free: 1-855-215-8180
PRINCIPAL DISPLAY PANEL
Daytime Cold and Flu Capsules (PE free)
Each softgel contains: Acetaminophen 325mg/ Dextromethorphan HBr 10mg
NDC 53345-056-01
Caution: for further manufacturing, processing or repackaing
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1867684 | acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule | PSN | 1 |
| 1867684 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral Capsule | SCD | 1 |
| 1867684 | acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule | SY | 1 |
| 1867684 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG Oral Capsule | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53345-056-01 | Daytime Cold and Flu | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | 1 | |
| 53345-056-01 | Daytime Cold and Flu | 4000 in 1 BAG | CAPSULE, LIQUID FILLED | 4000 | 1 |
Products#
Every source-derived product name is available through these pages.
- Daytime Cold and Flu
- Acetaminophen and Dextromethorphan hydrobromide
- GLYCERIN
- GELATIN TYPE B BOVINE (150 BLOOM)
- POLYETHYLENE GLYCOL 400
- WATER
- SORBITOL
- POVIDONE K12
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- SORBITAN
- ACETAMINOPHEN
- PROPYLENE GLYCOL
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 53345-056 | 53345-056-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| GELATIN TYPE B BOVINE (150 BLOOM) | F5AJW0ONK4 | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| POVIDONE K12 | 333AG72FWJ | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| SORBITAN | 6O92ICV9RU | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | 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 Cold and Flu | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd | 46996bbf-948c-0aba-e063-6394a90a09e3 | 2025-12-23 | Warnings | 53345-056-01 53345-056 53345005601 46995a36-4233-ddce-e063-6294a90a1b8e 46996bbf-948c-0aba-e063-6394a90a09e3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.