Indications and uses
Temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever
DAYTIME COLD AND FLU
- Manufacturer
- We Care Distributor Inc. | Softech Pharma Pvt. Ltd
- Effective date
- 2016-02-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-05-31 22:45:08
Label at a glance#
ProductDAYTIME COLD AND FLU
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
take only as directed - see Liver warning do not exceed 6 doses per 24 hours adults and children 12 years and over: 2 softgels with water every 4 hours children 4 to under 12 years: ask a doctor children under 4 years: do not use when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
Storage and handling
store at 20º-25ºC (68º-77ºF) read all product information before using. Keep this box for important information
Contacts and useful links#
Websitewww.wecaredistributor.com
www.wecaredistributor.com
www.wecaredistributor.comLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active Ingredient (in each softgel) | Purpose |
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
Phenylephrine HCl 5 mg | Nasal decongestant |
Uses
Temporarily relieves common cold/flu symptoms:
- nasal congestion
- 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 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Sore throat warning:
If sore throat is severe, lasts for more than 2 days, occurs with or is 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 monomine 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
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
When using this product
do not use more than directed
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
- new symptoms occur
- redness or swelling is present
- 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.
Directions
take only as directed - see Liver warning
do not exceed 6 doses per 24 hours
adults and children 12 years and over: 2 softgels with water every 4 hours
children 4 to under 12 years: ask a doctor
children under 4 years: do not use
when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
Other information
store at 20º-25ºC (68º-77ºF)
- read all product information before using. Keep this box for important information
Inactive ingredients
FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, methylparaben, polyethylene glycol, povidone, propylene glycol, propylparaben, purified water, sorbitol solution, titanium dioxide
Questions or comments?
1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com
PRINCIPAL DISPLAY PANEL
See New Warnings Information & Directions
Compare to the Active Ingredients in
DayQuil® LiquiCaps®
Acetaminophen, Dextromethorphan HBr and Phenylephrine HCl 325 mg, 10 mg and 5 mg
TO OPEN
PUSH IN TAB AND PULL OUT
25 Pouches of 2 Softgels Each
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 5 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 5 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | 5 |
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70005-003-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-31e4-f424-e053-dadaa90a57ce | DAYTIME COLD & FLU - Acetaminophen, Dextromethorphan HBr and Phenylephrine HCl |
| 70005-003-25 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-31e4-f424-e053-dadaa90a57ce | DAYTIME COLD & FLU - Acetaminophen, Dextromethorphan HBr and Phenylephrine HCl |
| 70005-003-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-31e4-f424-e053-dadaa90a57ce | DAYTIME COLD & FLU - Acetaminophen, Dextromethorphan HBr and Phenylephrine HCl |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70005-003-02 | DAYTIME COLD AND FLU | 2 in 1 POUCH | CAPSULE, LIQUID FILLED | 2 | 5 | |
| 70005-003-25 | DAYTIME COLD AND FLU | 25 in 1 BOX | CAPSULE, LIQUID FILLED | 25 | 5 | |
| 70005-003-25 | DAYTIME COLD AND FLU | 2 in 1 POUCH | CAPSULE, LIQUID FILLED | 2 | 5 | |
| 70005-003-50 | DAYTIME COLD AND FLU | 2 in 1 POUCH | CAPSULE, LIQUID FILLED | 2 | 5 | |
| 70005-003-50 | DAYTIME COLD AND FLU | 50 in 1 BOX | CAPSULE, LIQUID FILLED | 50 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70005-003 | DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL 325 MG, 10 MG AND 5 MG) CAPSULE, LIQUID FILLED [WE CARE DISTRIBUTOR INC.] | 5 | Legacy NDC, 5 package rows | 20160223_e1712db4-ab19-4fa6-a6fa-b45490d145c3.zip |
Products#
Every source-derived product name is available through these pages.
- DAYTIME COLD AND FLU
- Acetaminophen, Dextromethorphan HBr and Phenylephrine HCl 325 mg, 10 mg and 5 mg
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- GELATIN
- GLYCERIN
- METHYLPARABEN
- POLYETHYLENE GLYCOL 1000
- POVIDONE
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- SORBITOL
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70005-003 | 70005-003-25, 70005-003-50, 70005-003-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIM |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POLYETHYLENE GLYCOL 1000 | U076Q6Q621 | IACT |
| POVIDONE | FZ989GH94E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | 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 |
|---|---|---|---|---|---|---|
| 364c0bbe-0588-4ef9-933e-3bee49517e42 | e1712db4-ab19-4fa6-a6fa-b45490d145c3 | 2016-02-16 | Warnings | 364c0bbe-0588-4ef9-933e-3bee49517e42 e1712db4-ab19-4fa6-a6fa-b45490d145c3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.