Indications and uses
temporarily relieves nasal and sinus symptoms: sinus pain headache nasal and sinus congestion runny nose and sneezing (Nighttime only)
DayTime Nitetime Sinus Relief
- Manufacturer
- TOP CARE (Topco Associates LLC)
- Effective date
- 2019-08-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:17:30
Label at a glance#
ProductDayTime Nitetime Sinus Relief
Active ingredientACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure13 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. Nighttime : adults and children 12 years and over: take 2 softgels with water every 4 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 in Daytime (in each softgel)
Acetaminophen 325 mg
Phenylephrine HCl 5 mg
Active ingredients in Nighttime (in each softgel)
Acetaminophen 325 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg
Purpose for Daytime
Pain reliever
Nasal decongestant
Purpose for Nighttime
Pain reliever
Antihistamine
Nasal decongestant
Uses
- temporarily relieves nasal and sinus symptoms:
- sinus pain
- headache
- nasal and sinus congestion
- runny nose and sneezing (Nighttime 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
Do not use
- to make a child sleep (Nighttime 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
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
- glaucoma (Nighttime only)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (Nighttime only)
When using this product,
do not exceed recommended dosage. In addition, when using Nighttime:
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain or 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
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.
Nighttime: adults and children 12 years and over: take 2 softgels with water every 4 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 in Daytime
edible white ink, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Inactive ingredients in Nighttime
edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol
Questions or comments?
Call toll free 1-888-423-0139
Principal Display Panel
When using Daytime and Nighttime products, carefully read the labeling to insure correct dosing
NON-DROWSY Daytime Sinus Relief
PAIN RELIEVER AND NASAL DECONGESTANT
- Aches: ACETAMINOPHEN, 325 mg
- Nasal Congestion: Phenylephrine HCl, 5 mg
†Supports Children's Miracle Network Hospitals Helping Local Kids
DAYTIME SOFTGELS
MULTI-SYMPTOM Nitetime Sinus Relief
PAIN RELIEVER, ANTIHISTAMINE, AND NASAL DECONGESTANT
- Aches: ACETAMINOPHEN, 325 mg
- Sneezing/Runny Nose: Doxylamine succinate, 6.25 mg
- Nasal Congestion: Phenylephrine HCl, 5 mg
COMPARE TO VICKS® DAYQUIL® AND NYQUIL® SINEX® LIQUICAPS® active ingredients*
NITETIME SOFTGELS
*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® and NyQuil® Sinex® LiquiCaps®.
†A portion of the proceeds from this purchase will support the Children's Miracle Network Hospitals.
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
1-888-423-0139 topcare@topco.com
Product of Canada
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Product Label
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 4 | |
| DOXYLAMINE SUCCINATE | ACTIVE INGREDIENT | V9BI9B5YI2 | 4 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 4 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 4 | |
| DOXYLAMINE | ACTIVE MOIETY | 95QB77JKPL | 4 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 4 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 4 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 4 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 4 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 4 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 4 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | 4 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 4 | |
| SORBITAN | INACTIVE INGREDIENT | 6O92ICV9RU | 4 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 4 |
Products#
Every source-derived product name is available through these pages.
- DayTime Nitetime Sinus Relief
- Acetaminophen, Doxylamine succinate, Phenylephrine HCl
- Nitetime Sinus Relief
- ACETAMINOPHEN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- FD&C BLUE NO. 1
- GELATIN
- GLYCERIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- PROPYLENE GLYCOL
- WATER
- SORBITOL
- SORBITAN
- Daytime Sinus Relief
- Acetaminophen, Phenylephrine HCl
- FD&C YELLOW NO. 6
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 36800-102 | 36800-102-48 |
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 |
|---|---|---|---|---|---|---|
| POVIDONES | POVIDONE | FZ989GH94E | TABLET / ORAL | 216 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / RECTAL | 3315 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / OPHTHALMIC | 1 %w/v | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CONCENTRATE / ORAL | 0.03 mg/5ml | ||
| SORBITOL | SORBITOL | 506T60A25R | LIQUID / ORAL | 53460 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE / ORAL | 1072 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | SOLUTION / ORAL | 3000 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, ORALLY DISINTEGRATING / ORAL | 15.03 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / TOPICAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | POWDER / ORAL | 36000 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, SUSPENSION / INTRAMUSCULAR | 1.3 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | FILM / SUBLINGUAL | 0.03 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / OPHTHALMIC | 3 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED PELLETS / ORAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / ORAL | 2590 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRALESIONAL | 45 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SPONGE / TOPICAL | 0.01 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DOUCHE / VAGINAL | 1 %w/w | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, COATED / ORAL | 3.17 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR | 2 mg | ||
| SORBITAN | SORBITAN | 6O92ICV9RU | ELIXIR / ORAL | 0.6 ml/15ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / DENTAL | 2 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / ORAL | 29008 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / RECTAL | 0.01 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION, EXTENDED RELEASE / ORAL | 2000 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAVENOUS | 16624 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION, CONCENTRATE / ORAL | 300 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION, EXTENDED RELEASE / ORAL | 1000 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | LIQUID / TOPICAL | 1 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SHAMPOO / TOPICAL | 0.75 %w/w | ||
| SORBITOL | SORBITOL | 506T60A25R | CONCENTRATE / ORAL | 600 mg/1ml | ||
| GELATIN | GELATIN | 2G86QN327L | DROPS / NASAL | 50 mg/1ml | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | ELIXIR / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / TOPICAL | 1800 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPONGE / TOPICAL | 40 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / RECTAL | 1214 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, EXTENDED RELEASE / ORAL | 56 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / RECTAL | 27 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SYSTEM / TOPICAL | 6300 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | IMPLANT / SUBCUTANEOUS | 6 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, METERED / RECTAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / RESPIRATORY (INHALATION) | 5 %w/w | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET / SUBLINGUAL | 19 mg | ||
| GELATIN | GELATIN | 2G86QN327L | SYSTEM / TOPICAL | 1050 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION / TOPICAL | 3392 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOAP / TOPICAL | 0.01 %w/w |
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 |
|---|---|---|---|---|---|---|
| ace03272-f16e-4605-94bb-0df117c7e93f | 2b97d6d1-71b2-4689-9337-341b8cbe6fcf | 2019-08-01 | Warnings | ace03272-f16e-4605-94bb-0df117c7e93f 2b97d6d1-71b2-4689-9337-341b8cbe6fcf |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.