Indications and uses
temporarily relieves common cold and flu symptoms: sore throat headache minor aches and pains fever cough due to minor throat and bronchial irritation nasal congestion (Daytime only) runny nose and sneezing (Nitetime only)
DayTime Nitetime cold and flu relief
- Manufacturer
- Care One (American Sales Company)
- Effective date
- 2013-06-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:48:01
Label at a glance#
ProductDayTime Nitetime cold and flu relief
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure12 sections
Dosage and administration
do not take more than directed (see Overdose warning ) do not take more than 4 doses in 24 hours swallow whole; do not crush, chew, or dissolve Daytime : adults and children 12 years and over: take 2 softgels with water every 4 hours Nitetime : adults and children 12 years and over: take 2 softgels with water every 6 hours children under 12 years: do not use
Storage and handling
store at room temperature 15°-30°C (59°-86°F) avoid excessive heat
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients for Daytime (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Active ingredients for Nitetime (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Purpose for Daytime
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Purpose for Nighttime
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Uses
- temporarily relieves common cold and flu symptoms:
- sore throat
- headache
- minor aches and pains
- fever
- cough due to minor throat and bronchial irritation
- nasal congestion (Daytime only)
- runny nose and sneezing (Nitetime only)
Warnings
Liver warning: These products contain 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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
- to make a child sleep (Nitetime only)
- 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
- cough that occurs with too much phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, emphysema, and (for Nitetime only) chronic bronchitis
- glaucoma (Nitetime only)
- diabetes (Daytime only)
- heart disease (Daytime only)
- thyroid disease (Daytime only)
- high blood pressure (Daytime only)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (Nitetime only)
When using this product,
do not use more than directed.
In addition, when using Nitetime:
- excitability may occur, especially in children
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur (Daytime only)
- pain, cough, and (for Daytime only) nasal congestion 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.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center 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
- do not take more than directed (see Overdose warning )
- do not take more than 4 doses in 24 hours
- swallow whole; do not crush, chew, or dissolve
Daytime: adults and children 12 years and over: take 2 softgels with water every 4 hours
Nitetime: adults and children 12 years and over: take 2 softgels with water every 6 hours
- children under 12 years: do not use
Other information
- store at room temperature 15°-30°C (59°-86°F)
- avoid excessive heat
Inactive ingredients
Daytime butylated hydroxyanisole, butylated hydroxytoluene, edible white ink, FD&C red #40*, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
*may contain this ingredient
Nitetime D&C yellow #10, edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan sorbitol
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the Active Ingredients in Vicks® DayQuil® and NyQuil® LiquiCaps®†
NON-DROWSY DAYTIME / MULTI-SYMPTOM NITETIME
COLD/FLU RELIEF LIQUID CAPS
Acetaminophen - Pain Reliever-Fever Reducer / Acetaminophen - Pain Reliever-Fever Reducer
Dextromethorphan HBr - Cough Suppressant / Dextromethorphan HBr - Cough Suppressant
Phenylephrine HCl - Nasal Decongestant / Doxylamine Succinate - Antihistamine
DAYTIME SOFTGELS / NITETIME SOFTGELS
Alcohol Free
Antihistamine Free
When using Daytime and Nitetime products, carefully read the labeling to insure correct dosing
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
DISTRIBUTED BY
FOODHOLD U.S.A., LLC
LANDOVER, MD 20785
†This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® and NyQuil® LiquiCaps®.
Product Label
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 3 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 3 | |
| DOXYLAMINE SUCCINATE | ACTIVE INGREDIENT | V9BI9B5YI2 | 3 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 3 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 3 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 3 | |
| DOXYLAMINE | ACTIVE MOIETY | 95QB77JKPL | 3 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 3 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | 3 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 3 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 3 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 3 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 3 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 3 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 3 | |
| SORBITAN | INACTIVE INGREDIENT | 6O92ICV9RU | 3 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 3 |
Products#
Every source-derived product name is available through these pages.
- DayTime Nitetime cold and flu relief
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
- Nitetime
- Acetaminophen, Dextromethorphan hydrobromide, Doxylamine Succinate
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- D&C YELLOW NO. 10
- FD&C BLUE NO. 1
- GELATIN
- GLYCERIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- PROPYLENE GLYCOL
- WATER
- SORBITAN
- SORBITOL
- Daytime
- acetaminophen, dextromethorphan HBr, phenylephrine HCl
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- BUTYLATED HYDROXYANISOLE
- BUTYLATED HYDROXYTOLUENE
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 41520-491 | 41520-491-48 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| SORBITAN | SORBITAN | 6O92ICV9RU | CAPSULE, LIQUID FILLED / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / OPHTHALMIC | 1.5 %w/v | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, EXTENDED RELEASE / ORAL | 4.59 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / TOPICAL | 0.01 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / RESPIRATORY (INHALATION) | 25 %w/w | ||
| GELATIN | GELATIN | 2G86QN327L | SYSTEM / TOPICAL | 1050 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / BUCCAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | JELLY / TOPICAL | 20 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT, AUGMENTED / TOPICAL | 714 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET, DELAYED RELEASE / ORAL | 1.9 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED / ORAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | GRANULE, FOR SUSPENSION / ORAL | NA | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / TOPICAL | 5.28 %w/v | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED / ORAL | 0.03 mg | ||
| GELATIN | GELATIN | 2G86QN327L | SOLUTION / INTRAVENOUS | 34.8 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / RECTAL | 440 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CREAM, AUGMENTED / TOPICAL | 0.2 %w/w | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAMUSCULAR | 7459 mg | ||
| GELATIN | GELATIN | 2G86QN327L | DROPS / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CREAM / TOPICAL | 0.01 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CLOTH / TOPICAL | 0.05 mg/mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, DELAYED RELEASE / ORAL | 1791 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | ELIXIR / ORAL | 833.3 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SPRAY / NASAL | 49 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED PELLETS / ORAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | GUM, CHEWING / BUCCAL | 48 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | INJECTION / INTRAMUSCULAR | 0.2 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SHAMPOO / TOPICAL | 5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET / ORAL | 337.28 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE, DELAYED RELEASE / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DOUCHE / VAGINAL | 1 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | GEL / DENTAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL / TOPICAL | 19.2 %w/w | ||
| GELATIN | GELATIN | 2G86QN327L | GUM, CHEWING / BUCCAL | 102 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SWAB / TOPICAL | 0.5 %w/w | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET / SUBLINGUAL | 19 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, EMULSION / INTRAVENOUS | 24100 mg | ||
| GELATIN | GELATIN | 2G86QN327L | PASTILLE / ORAL | 143 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SOLUTION / RECTAL | NA | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CAPSULE, LIQUID FILLED / ORAL | 0.1 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | GUM, CHEWING / BUCCAL | 5 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 63.4 %w/v | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | GEL / TOPICAL | 8 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE, DENTIFRICE / DENTAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, DELAYED RELEASE / ORAL | 1.7 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOLUTION / RECTAL | 0.5 %w/v |
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 |
|---|---|---|---|---|---|---|
| 985662a0-7a67-4031-8538-3f7d9d4f4dae | 196d8d95-a2db-4695-b3b5-daced8417f5b | 2013-06-20 | Warnings | 985662a0-7a67-4031-8538-3f7d9d4f4dae 196d8d95-a2db-4695-b3b5-daced8417f5b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.