Indications and uses
temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches/pains fever runny nose and sneezing
NightTime Cold and Flu
- Manufacturer
- MEIJER DISTRIBUTION, INC
- Effective date
- 2022-11-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:46:29
Label at a glance#
ProductNightTime Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure9 sections
Dosage and administration
Take only as recommended—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 6 hours children 4 to under 12 years of age ask a doctor children under 4 years of age do not use When using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
Storage and handling
store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
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 15 mg | Cough suppressant |
| Doxylamine Succinate 6.25 mg | Antihistamine |
Uses
temporarily relieves common cold/flu symptoms:
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches/pains
- fever
- runny nose and sneezing
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
Sore throat warning
If sore throat is severe, lasts for more than 2 days, or occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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.
- to make a child sleep
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- liver disease
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- trouble urinating due to enlarged prostate gland
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood-thinning drug warfarin.
OTC - WHEN USING SECTION
When using this product
- do not use more than directed
- excitability may occur especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- be careful with driving a motor vehicle or operating machinery
- alcohol, sedatives and tranquilizers may increase drowsiness
OTC - STOP USE SECTION
Stop use and ask a doctor if
- pain or cough 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
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 the recommended dose 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 as well as for children, even if you do not notice any signs or symptoms.
Directions
- Take only as recommended—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 6 hours children 4 to under 12 years of age ask a doctor children under 4 years of age do not use
When using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
Other information
- store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
Inactive ingredients
D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide
Questions or comments?
1-888-333-9792
PRINCIPAL DISPLAY PANEL
COMPARE TO ACTIVE INGREDIENTS IN
VICKS® NYQUIL® LiquiCaps® active ingredients†
MULTI-SYMPTOM
NIGHTTIME COLD & FLU
Acetaminophen 325mg/ ACHES/ FEVER/ SORE THROAT
Dextromethorphan HBr 15mg/ COUGH
Doxylamine Succinate 6.25mg/ SNEEZING/ RUNNY NOSE
Relieves aches, fever, sore throat,
cough, sneezing & runny nose
Actual Size
24 LIQUID CAPS
†This product is not manufactured or distributed by
Procter & Gamble, owner of the registered
trademarks Vicks® NyQuil® LiquiCaps®
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 41250-586-24 | 2024-01-31 | C162847 | 48780-1 | 1030e365-2ea9-111a-e063-dadaa90a10e2 | NightTime Cold and Flu |
Products#
Every source-derived product name is available through these pages.
- NightTime Cold and Flu
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and DOXYLAMINE SUCCINATE
- D&C YELLOW NO. 10
- FD&C BLUE NO. 1
- GELATIN
- GLYCERIN
- POLYETHYLENE GLYCOL 400
- POVIDONE, UNSPECIFIED
- PROPYLENE GLYCOL
- WATER
- SORBITOL
- TITANIUM DIOXIDE
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 41250-586 | 41250-586-24 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | 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 |
|---|---|---|---|---|---|---|
| 104397e7-cdf2-7736-e063-6294a90abde3 | 542f61a5-4048-44d0-bede-f7b0e56fa6bd | 2024-01-31 | Warnings | 542f61a5-4048-44d0-bede-f7b0e56fa6bd |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.