Indications and uses
temporarily relieves common cold/flu symptoms: nasal congestion cough due to minor throat & bronchial irritation sore throat headache minor aches/pains fever
MULTI-SYMPTOM DAYTIME
- Manufacturer
- SPIRIT PHARMACEUTICALS LLC
- Effective date
- 2024-12-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-06-01 00:43:09
Label at a glance#
ProductMULTI-SYMPTOM DAYTIME
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
Take only as directed—see Overdose warning . do not exceed 4 doses per 24 hours. adults and children 12 years of age and over swallow 2 softgels with water every 4 hours children 4 to under 12 years of age ask a doctor children under 4 years of age do not use If taking Daytime and Nighttime softgels carefully read each label to insure correct dosing
Storage and handling
store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat this product does not contain phenylpropanolamine
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredients (in each softgel) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan Hydrobromide 10 mg | Cough suppressant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
Uses
temporarily relieves common cold/flu symptoms:
- nasal congestion
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches/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
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, see 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.
Ask a doctor before use if you have
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- trouble urinating due to enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
OTC - ASK DOCTOR/PHARMACIST SECTION
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 last 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
Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children, even if you do not notice any signs or symptoms.
Directions
- Take only as directed—see Overdose warning.
- do not exceed 4 doses per 24 hours.
| adults and children 12 years of age and over | swallow 2 softgels with water every 4 hours |
| children 4 to under 12 years of age | ask a doctor |
| children under 4 years of age | do not use |
If taking Daytime and Nighttime softgels carefully read each label to insure correct dosing
Other information
- store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
- this product does not contain phenylpropanolamine
Inactive ingredients
FD&C Red No. 40, FD&C Yellow No.6. gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide
Questions or comments?
1-888-333-9792
SPL UNCLASSIFIED SECTION
THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.
PRINCIPAL DISPLAY PANEL
SEE NEW WARNINGS INFORMATION
COMPARE TO ACTIVE INGREDIENTS IN
VICKS
® DAYQUIL
®*
VALUMEDS™
NON-DROWSY
DAY TIME
COLD & FLU MULTI-SYMPTOM RELIEF
ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
Pain Reliever
- Fever Reducer
- Cough Suppressant
- Nasal Decongestant
16 SOFTGELS
Liquid filled capsules
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 7 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 7 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | 7 |
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#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68210-4010-1 | 2026-01-29 | C162847 | 48780-1 | f386c64a-1624-0266-e053-dadaa90a7c1a | VALUMEDS DAY TIME COLD & FLU MULTI-SYMPTOM RELIEF |
| 68210-4010-2 | 2026-01-29 | C162847 | 48780-1 | f386c64a-1624-0266-e053-dadaa90a7c1a | VALUMEDS DAY TIME COLD & FLU MULTI-SYMPTOM RELIEF |
| 68210-4010-1 | 2023-12-08 | C162847 | 48780-1 | f386c64a-1624-0266-e053-dadaa90a7c1a | VALUMEDS DAY TIME COLD & FLU MULTI-SYMPTOM RELIEF |
| 68210-4010-2 | 2023-12-08 | C162847 | 48780-1 | f386c64a-1624-0266-e053-dadaa90a7c1a | VALUMEDS DAY TIME COLD & FLU MULTI-SYMPTOM RELIEF |
| 68210-4010-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1624-0266-e053-dadaa90a7c1a | VALUMEDS DAY TIME COLD & FLU MULTI-SYMPTOM RELIEF |
| 68210-4010-2 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1624-0266-e053-dadaa90a7c1a | VALUMEDS DAY TIME COLD & FLU MULTI-SYMPTOM RELIEF |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68210-4010-1 | MULTI-SYMPTOM DAYTIME | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 7 | |
| 68210-4010-1 | MULTI-SYMPTOM DAYTIME | 16 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 16 | 7 | |
| 68210-4010-2 | MULTI-SYMPTOM DAYTIME | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 7 | |
| 68210-4010-2 | MULTI-SYMPTOM DAYTIME | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68210-4010 | MULTI-SYMPTOM DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC] | 7 | Legacy NDC, 4 package rows | 20241215_4348cf8a-543b-449f-b9c4-6ca059ec1933.zip |
Products#
Every source-derived product name is available through these pages.
- MULTI-SYMPTOM DAYTIME
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
- FD&C YELLOW NO. 6
- FD&C RED NO. 40
- GELATIN
- GLYCERIN
- POLYETHYLENE GLYCOL 400
- POVIDONE K30
- PROPYLENE GLYCOL
- WATER
- SORBITOL
- TITANIUM DIOXIDE
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68210-4010 | 68210-4010-1, 68210-4010-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
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 |
|---|---|---|---|---|---|---|
| 292c447d-ea06-2df7-e063-6294a90aabf6 | 4348cf8a-543b-449f-b9c4-6ca059ec1933 | 2024-12-13 | Warnings | 292c447d-ea06-2df7-e063-6294a90aabf6 4348cf8a-543b-449f-b9c4-6ca059ec1933 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.