Indications and uses
temporarily relieves common cold and flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever, runny nose and sneezing
temporarily relieves common cold and flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever, runny nose and sneezing
■ take only as recommended (see Warnings) ■ do not exceed 4 doses per 24 hours Adults and children 12 years and over: ■ take 2 softgels with water every 6 hours Children 4 to under 12 years: ■ Ask a doctor Children under 4 years: ■ Do not use
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Pain reliever/fever reducer
Cough suppressant
Antihistamine
temporarily relieves common cold and flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever, runny nose and sneezing
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 productwith other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product
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.
with any other products 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 drugs. 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
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
do not exceed recommended dosage excitability may occur, especially in childrenmarked drowsiness may occur avoid alcoholic drink be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness
pain or cough gets worse or lasts more than 7 days fever gets worse or last 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.
ask a health professional before use
In case of accidental overdose, contact a doctor or Poison Control Center immediately (1-800-222-1222). Taking more than the recommended dose can cause serious health problems. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
■ take only as recommended (see Warnings)
■ do not exceed 4 doses per 24 hours
Adults and children 12 years and over: ■ take 2 softgels with water every 6 hours
Children 4 to under 12 years: ■ Ask a doctor
Children under 4 years: ■ Do not use
store at room temperature do not use if blister is torn or open
FD&C Green #3, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol. May also contain FD&C Blue #1, D&C Yellow Yellow #10, titanium dioxide.
Call toll free 1-877-99-GENOM (43666)
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 2 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 2 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 2 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50066-357-09 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-2037-f424-e053-dadaa90a57ce | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50066-357-09 | Next Night TimeCold and Flu Relief | 10 in 1 BOX | CAPSULE, LIQUID FILLED | 10 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50066-357 | NEXT NIGHT TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [GENOMMA LAB USA] | 2 | Legacy NDC, 1 package rows | 20150417_1c791a43-03db-402b-a9db-b4b4f4b764af.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 2 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 2 | |
| DOXYLAMINE SUCCINATE | ACTIVE INGREDIENT | V9BI9B5YI2 | 2 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 2 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 2 | |
| DOXYLAMINE | ACTIVE MOIETY | 95QB77JKPL | 2 | |
| FD&C GREEN NO. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | 2 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50066-357 | 50066-357-09 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
| FD&C GREEN NO. 3 | 3P3ONR6O1S | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POVIDONES | FZ989GH94E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | CNTM |
| D&C YELLOW NO. 10 | 35SW5USQ3G | CNTM |
| TITANIUM DIOXIDE | 15FIX9V2JP | CNTM |
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 |
|---|---|---|---|---|---|---|
| SORBITOL | SORBITOL | 506T60A25R | POWDER, FOR SUSPENSION / ORAL | 12000 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET / SUBLINGUAL | 50.5 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / OPHTHALMIC | 0.44 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / DENTAL | 2 %w/w | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, EXTENDED RELEASE / ORAL | 1229 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / OPHTHALMIC | 0.6 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAVENOUS | 4000 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | LOTION / TOPICAL | 10.7 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | AEROSOL, POWDER / TOPICAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / TOPICAL | 1971 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 1.04 %w/v | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | INJECTION / INTRAVENOUS | 28216 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION, CONCENTRATE / ORAL | 300 mg/1ml | ||
| FD&C GREEN NO. 3 | FD&C GREEN NO. 3 | 3P3ONR6O1S | CAPSULE, LIQUID FILLED / ORAL | 0.03 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SOLUTION/ DROPS / OPHTHALMIC | 0.25 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / ORAL | 29008 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / TOPICAL | 4886 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | IMPLANT / SUBCUTANEOUS | 6 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 14 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / RECTAL | 1214 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / VAGINAL | 227.9 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | GEL / TOPICAL | 6300 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg | ||
| FD&C GREEN NO. 3 | FD&C GREEN NO. 3 | 3P3ONR6O1S | GEL / DENTAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| FD&C GREEN NO. 3 | FD&C GREEN NO. 3 | 3P3ONR6O1S | SOLUTION / TOPICAL | NA | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, ORALLY DISINTEGRATING / ORAL | 120 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / TOPICAL | 5.28 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT, AUGMENTED / TOPICAL | 714 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / RECTAL | 90400 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, EXTENDED RELEASE / ORAL | 9 mg | ||
| FD&C GREEN NO. 3 | FD&C GREEN NO. 3 | 3P3ONR6O1S | SOLUTION / ORAL | 0.25 mg/5ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | ELIXIR / ORAL | 9306 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | POWDER, FOR SUSPENSION / ORAL | 35 mg/5ml | ||
| GELATIN | GELATIN | 2G86QN327L | POWDER, FOR SUSPENSION / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / RECTAL | 3315 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TAMPON / VAGINAL | 62.1 mg | ||
| GELATIN | GELATIN | 2G86QN327L | SYRUP / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | OINTMENT / TOPICAL | 1950 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, LIQUID FILLED / ORAL | 1042 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | SYSTEM / TOPICAL | 41 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 63.4 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRAMUSCULAR | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| GELATIN | GELATIN | 2G86QN327L | SYSTEM / TOPICAL | 1050 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, SUGAR COATED / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET / ORAL | 64 mg |
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 |
|---|---|---|---|---|---|---|
| 574f4302-2db9-48b8-94f6-c0671fa38846 | 1c791a43-03db-402b-a9db-b4b4f4b764af | 2015-01-21 | Warnings | 574f4302-2db9-48b8-94f6-c0671fa38846 1c791a43-03db-402b-a9db-b4b4f4b764af |
Adverse event summaries are temporarily unavailable. Other product information remains available.