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 & sneezing
NiteTime Multi-Symptom Liquid Capsules Cold/Flu Relief
- Manufacturer
- Greenbrier International
- Effective date
- 2014-01-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:34:58
Label at a glance#
ProductNiteTime Multi-Symptom Cold/Flu Relief
Active ingredientAcetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Label structure11 sections
Dosage and administration
take only as directed - see Overdose warning do not exceed 4 doses per 24 hrs Adults & children 12 years and over 2 softgels with water every 6 hrs Children 4 to under 12 years ask a doctor Children under 4 years do not use
Storage and handling
store at room temperature
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active Ingredient
Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Purpose
Purpose
Pain reliever/fever reducer
Cough suppressant
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 & 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 daily 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, 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
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
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
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 when driving a motor vehicle or operating machinery
- alcohol, sedatives, & tranquilizers may increase drowsiness
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 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 & 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 hrs
| Adults & children 12 years and over | 2 softgels with water every 6 hrs |
| Children 4 to under 12 years | ask a doctor |
| Children under 4 years | do not use |
Other information
- store at room temperature
Inactive ingredients
D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, methylparaben, polyethylene glycol, povidone, propylene glycol, propylparaben, purified water, sorbitol, titanium dioxide
Questions?
1-866-467-2748
SPL UNCLASSIFIED SECTION
This product is not manufactured or distributed by Procter & Gamble, distributor of Vicks® Nyquil® Cold & Flu Liquicaps®
PRINCIPAL DISPLAY PANEL - 10 Softgel Carton
Assured
Multi-Symptom
NiteTime
Acetaminophen, Doxylamine, Dextromethorphan HBr
Cold/Flu Relief
- Aches & Sore Throat
- Sneezing, Runny Nose
- Cough
10 Softgels
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 1 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 1 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 33992-0621-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-b452-f424-e053-dadaa90a57ce | NiteTime Multi-Symptom Liquid Capsules Cold/Flu Relief |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 33992-0621-0 | NiteTimeMulti-Symptom Cold/Flu Relief | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | 1 | |
| 33992-0621-0 | NiteTimeMulti-Symptom Cold/Flu Relief | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 33992-0621 | NITETIME MULTI-SYMPTOM COLD/FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [GREENBRIER INTERNATIONAL] | 1 | Legacy NDC, 2 package rows | 20130322_e278b8ad-2eb0-4bd8-a455-a8a438e87f97.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Acetaminophen | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| Dextromethorphan Hydrobromide | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| Doxylamine Succinate | ACTIVE INGREDIENT | V9BI9B5YI2 | 1 | |
| Acetaminophen | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| Dextromethorphan | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| Doxylamine | ACTIVE MOIETY | 95QB77JKPL | 1 | |
| D&C Yellow No. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 1 | |
| FD&C Blue No. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| gelatin | INACTIVE INGREDIENT | 2G86QN327L | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| sorbitol | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- NiteTime Multi-Symptom Cold/Flu Relief
- Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate
- Acetaminophen
- Dextromethorphan Hydrobromide
- Dextromethorphan
- Doxylamine Succinate
- Doxylamine
- D&C Yellow No. 10
- FD&C Blue No. 1
- gelatin
- glycerin
- METHYLPARABEN
- polyethylene glycols
- POVIDONES
- propylene glycol
- PROPYLPARABEN
- water
- sorbitol
- titanium dioxide
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 33992-0621 | 33992-0621-0 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Acetaminophen | 362O9ITL9D | ACTIB |
| Dextromethorphan Hydrobromide | 9D2RTI9KYH | ACTIB |
| Doxylamine Succinate | V9BI9B5YI2 | ACTIB |
| D&C Yellow No. 10 | 35SW5USQ3G | IACT |
| FD&C Blue No. 1 | H3R47K3TBD | IACT |
| gelatin | 2G86QN327L | IACT |
| glycerin | PDC6A3C0OX | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| polyethylene glycols | 3WJQ0SDW1A | IACT |
| POVIDONES | FZ989GH94E | IACT |
| propylene glycol | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| water | 059QF0KO0R | IACT |
| sorbitol | 506T60A25R | IACT |
| titanium dioxide | 15FIX9V2JP | IACT |
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 |
|---|---|---|---|---|---|---|
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRAVENOUS | 95 mg | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE, EXTENDED RELEASE / ORAL | 3 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | FILM / BUCCAL | 0.22 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| gelatin | GELATIN | 2G86QN327L | DROPS / NASAL | 50 mg/1ml | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CREAM, AUGMENTED / TOPICAL | 55 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / TOPICAL | 8 %w/w | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, EXTENDED RELEASE / ORAL | 56 mg | ||
| sorbitol | SORBITOL | 506T60A25R | CONCENTRATE / ORAL | 600 mg/1ml | ||
| glycerin | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM / SUBLINGUAL | 0.07 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| glycerin | GLYCERIN | PDC6A3C0OX | EMULSION / OPHTHALMIC | 3 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / ORAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / ORAL | 346 mg | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET / ORAL | 80 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CLOTH / TOPICAL | 0.03 mg/mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SOLUTION / INTRAVENOUS | 5 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE, DENTIFRICE / DENTAL | NA | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, FILM COATED / ORAL | 240 mg | ||
| sorbitol | SORBITOL | 506T60A25R | GUM, CHEWING / ORAL | 6168 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE / ORAL | 20 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| gelatin | GELATIN | 2G86QN327L | INJECTION / INTRAMUSCULAR | 16 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION, CONCENTRATE / ORAL | 1 mg/1ml | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM / TOPICAL | 3000 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CONCENTRATE / ORAL | 12 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM / TOPICAL | 6 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 0.4 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / TOPICAL | 0.16 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL, METERED / TOPICAL | 1225 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / TOPICAL | 0.75 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | ELIXIR / ORAL | 200 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / SUBCUTANEOUS | 0.02 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / AURICULAR (OTIC) | 0.01 %w/w | ||
| sorbitol | SORBITOL | 506T60A25R | CREAM, AUGMENTED / TOPICAL | 15 %w/w | ||
| sorbitol | SORBITOL | 506T60A25R | LIQUID / ORAL | 53460 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 32 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, DELAYED RELEASE / ORAL | 1.7 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | DROPS / ORAL | 200 mg/1ml | ||
| D&C Yellow No. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET, COATED / ORAL | 2.5 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / SUBLINGUAL | 0.03 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SYSTEM / TOPICAL | 21 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | IMPLANT / SUBCUTANEOUS | 6 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CREAM / TOPICAL | 0.01 %w/w | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, METERED / RECTAL | NA | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / TOPICAL | 1800 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRA-ARTICULAR | 0.03 %w/v | ||
| POVIDONES | POVIDONE | FZ989GH94E | TROCHE / ORAL | 30 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg |
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 |
|---|---|---|---|---|---|---|
| e278b8ad-2eb0-4bd8-a455-a8a438e87f97 | e278b8ad-2eb0-4bd8-a455-a8a438e87f97 | 2014-01-02 | Boxed warning, Warnings | e278b8ad-2eb0-4bd8-a455-a8a438e87f97 e278b8ad-2eb0-4bd8-a455-a8a438e87f97 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.