Indications and uses
temporarily relieves these common cold and flu symptoms: cough due to minor throat and bronchial irritation runny nose and sneezing minor aches and pains sore throat headache fever the impulse to cough to help you get to sleep
Delsym Night Time
- Manufacturer
- Reckitt Benckiser LLC
- Effective date
- 2011-12-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:49:55
Label at a glance#
ProductDelsym Night Time Multi-Symptom
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure10 sections
Dosage and administration
do not take more than directed (see Overdose warning ) do not take more than 4 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor mL = milliliter Adults and Children 12 years and older: 30 mL in dosing cup provided every 6 hours. Children under 12 years of age: Do not use.
Storage and handling
each 15 mL contains: sodium 19 mg dosing cup provided store between 20-25°C (68-77°F) Keep carton for full directions for use
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 15 mL) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/Fever reducer |
| Dextromethorphan HBr 15 mg | Cough suppressant |
| Doxylamine Succinate 6.25 mg | Antihistamine |
Uses
temporarily relieves these common cold and flu symptoms:
- cough due to minor throat and bronchial irritation
- runny nose and sneezing
- minor aches and pains
- sore throat
- headache
- fever
- the impulse to cough to help you get to sleep
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
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Sore throat warning
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.
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 sleepy
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
- cough that occurs with too much phlegm (mucus)
- a sodium restricted diet
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin.
- taking sedatives or tranquilizers.
When using this product
- do not use more than directed
- excitability may occur, especially in children
- marked drowsiness may occur
- alcohol, sedatives and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
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 persistent headache. 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 (overdose) may 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 any 24-hour period
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- mL = milliliter
- Adults and Children 12 years and older: 30 mL in dosing cup provided every 6 hours.
- Children under 12 years of age: Do not use.
Other information
- each 15 mL contains: sodium 19 mg
- dosing cup provided
- store between 20-25°C (68-77°F)
- Keep carton for full directions for use
Inactive ingredients
alcohol, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate
Questions?
1-888-963-3382
You may also report side effects to this phone number.
SPL UNCLASSIFIED SECTION
Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224
PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
NEW FORMULA – SEE NEW DOSING DIRECTIONS!
NDC 63824-186-64
Delsym®
NIGHT
TIME
MULTI-SYMPTOM
Acetaminophen
(Pain Reliever/Fever Reducer)
Dextromethorphan HBr (Cough Suppressant)
Doxylamine succinate (Antihistamine)
- Cough
- Fever & Body Aches
- Sore Throat
- Sneezing
- Runny Nose
10% ALCOHOL
Cherry
Flavored
Liquid
120 mL (4 fl oz)
for Ages 12+
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63824-186-64 | 2024-10-08 | C162847 | 48780-1 | 9d75b9d0-3f04-f424-e053-dadaa90a57ce | Delsym ® Night Time Multi-Symptom |
| 63824-186-64 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-3f04-f424-e053-dadaa90a57ce | Delsym ® Night Time Multi-Symptom |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63824-186-64 | ML - Milliliter | 63824-186 | d716dee9-fc77-4c1c-8502-59c56e409f5c | 1 | 2012-07-24 |
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 |
Products#
Every source-derived product name is available through these pages.
- Delsym Night Time Multi-Symptom
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and DOXYLAMINE SUCCINATE
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- ALCOHOL
- ANHYDROUS CITRIC ACID
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- HIGH FRUCTOSE CORN SYRUP
- POLYETHYLENE GLYCOLS
- PROPYLENE GLYCOL
- WATER
- SACCHARIN SODIUM DIHYDRATE
- SODIUM CITRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63824-186 | 63824-186-64 |
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 |
| ALCOHOL | 3K9958V90M | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | IACT |
| POLYETHYLENE GLYCOLS | 3WJQ0SDW1A | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM DIHYDRATE | SB8ZUX40TY | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
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 |
|---|---|---|---|---|---|---|
| 23f9a405-cd42-f766-e063-6394a90abb4b | 3fd31f1c-0fab-4fd2-a0f1-56ade1f013f0 | 2024-10-08 | Warnings | 3fd31f1c-0fab-4fd2-a0f1-56ade1f013f0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.