Indications and uses
temporarily relieves common cold/flu symptoms: • sore throat • minor aches and pains • runny nose and sneezing • headache • fever • cough due to minor throat and bronchial irritation.
temporarily relieves common cold/flu symptoms: • sore throat • minor aches and pains • runny nose and sneezing • headache • fever • cough due to minor throat and bronchial irritation.
• take only as directed (see overdose warning) • measure only with dosing cup provided and keep dosage cup with product • mL=mililiter • do not exceed 4 doses per 24 hours Age Dose adults and children 12 years and over 30 mL every 6 hours children under 12 years do not use
Active ingredients (in each 30 mL dose cup)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine Succinate 12.5 mg
Pain Reliever/Fever Reducer
Cough Suppressant
Antihistamine
temporarily relieves common cold/flu symptoms:
• sore throat
• minor aches and pains
• runny nose and sneezing
• headache
• fever
• cough due to minor throat and bronchial irritation.
Liver warning:This product contains acetaminophen. Severe liver damage may occur if:
• adults and children over 12 years of age take more than 4 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks every day while using this product.
Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:
• skin reddening
• blisters
• rash. If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning:If sore throat is severe, lasts for mroe than 2 days, is accompanied or followed by fever, heacache, rash, nausea, or vomiting, consult a doctor promptly.
• 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.
• if you have ever had an allergic reaction to this product or anay of its ingredients
• liver disease
• glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occur with smoking, asthma, chronic bronchitis or emphysema
• trouble urinating due to an enlarged prostate gland.
• do not use more than directed (see overdose warning)
• avoid alcoholic drinks
• excitability may occur, especially in children
• marked drowsiness may occur
• 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 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.
ask a health professional before use.
Keep out of the reach of children.
Taking mroe than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately.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 directed (see overdose warning)
• measure only with dosing cup provided and keep dosage cup with product
• mL=mililiter
• do not exceed 4 doses per 24 hours
| Age | Dose |
| adults and children 12 years and over | 30 mL every 6 hours |
| children under 12 years | do not use |
• Each 30 mL dose cup contains:sodium 10 mg
• store at room temperature 15-30°C (59-86°F) and do not refrigerate
citric acid, D&C Yellow #10, FD&C Green #3, FD&C Yellow #6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.
1-844-912-4012
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 1 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 1 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 1 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 1 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 37835-525-12 | NIGHTTIME COLD AND FLU | 355 mL in 1 BOTTLE | LIQUID | 355 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 37835-525 | 37835-525-12 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| WATER | 059QF0KO0R | IACT |
| FD&C GREEN NO. 3 | 3P3ONR6O1S | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| MENTHOL | L7T10EIP3A | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| SORBITOL SOLUTION 70% | 8KW3E207O2 | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| 3590d417-272f-ae4d-e063-6394a90a5dc6 | 36aa5df7-8722-4b80-aa04-d869bc944311 | 2025-05-01 | Warnings | 3590d417-272f-ae4d-e063-6394a90a5dc6 36aa5df7-8722-4b80-aa04-d869bc944311 |
Adverse event summaries are temporarily unavailable. Other product information remains available.