XL-3 Night Time
- Manufacturer
- Rnv LLC
- Effective date
- 2026-01-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 01:35:17
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredientes
(in each 30mL dose cup)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine Succinate 12.5 mg
OTC - PURPOSE SECTION
Pain reliever/fever reducer
Cough Suppressant
Antihistamine
INDICATIONS & USAGE SECTION
Uses
temporarily relieves cold/flu symptoms:
- sore throat
- headache
- minor aches and pain
- fever
- runny nose and sneezing
- cough due to minor throat and bronchial irritation
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen. Sever liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause sever skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is sever, persist for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly
OTC - DO NOT USE SECTION
Do not use
with any other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
- for more than 10 days for pain unless directed by a doctor
- for more than 3 days for fever unless directed by a doctor
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's diseas), 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 sleepy
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- a sodium restricted diet
- liver disease
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs wtih 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
- if you are taking the blood thinning drug warfarin.
OTC - WHEN USING SECTION
When using this product
- do not use more than directed
- 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.
OTC - STOP USE SECTION
Stop use and ask a doctor if
- redness or swelling is present
- symptoms do not get better within 7 days or are accompanied by a fever
- fever gets worse or lasts more than 3 days
- new symptoms occur
- cough lasts more than 7 days, comes back, or occurs wih fever, 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.
OVERDOSAGE SECTION
Overdose warning: Taking more than the recommended dose (overdose) may cause serious health problems including liver damage. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
DOSAGE & ADMINISTRATION SECTION
- take only as recommended- see Overdose warning
- use only dosing cup provided
- keep dosing cup provided with the product
- do not exceed 4 doses per 24 hours
- if taking Day Time during the day and Night Time at night, limit the total to 4 doses per 24 hours
- TBSP=tablespoon
- mL=mililiter
adults & children 12 years and over | 30 mL (2 TBSP) every 6 hours |
| children 4 to under 12 years | ask a doctor |
| children under 4 years | do not use |
OTHER SAFETY INFORMATION
Other information
- each 30 mL contains: sodium 10 mg
- store between 58° - 86°F (15°-30° degrees C)
INACTIVE INGREDIENT SECTION
Inactive ingredients: Citric acid, FD&C Blue #1, FD&C Red #40, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.
OTC - QUESTIONS SECTION
Questions or Comments? 1-888-446-4753
Monday - Friday from 8 AM - 5 PM Eastern Standard Time
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| 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 | 3 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 3 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 3 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 3 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 3 |
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 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0645981000290 | GTIN-13: 0645981000290 EAN-13: 0645981000290 GTIN-12: 645981000290 UPC-A: 645981000290 GTIN storage (14 digits): 00645981000290 | XL-3 NIGHT TIME 12oz.jpg |
| Barcode | EAN-13 | 0645981000351 | GTIN-13: 0645981000351 EAN-13: 0645981000351 GTIN-12: 645981000351 UPC-A: 645981000351 GTIN storage (14 digits): 00645981000351 | XL-3 NIGHT TIME 6oz.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84379-444-06 | XL-3 Night Time | 177 mL in 1 BOTTLE | LIQUID | 177 | 3 | |
| 84379-444-12 | XL-3 Night Time | 354 mL in 1 BOTTLE | LIQUID | 354 | 3 |
Products#
Every source-derived product name is available through these pages.
- XL-3 Night Time
- acetaminophen, dextromethorphan HBr, Doxylamine Succinate
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- PROPYLENE GLYCOL
- FD&C RED NO. 40
- SODIUM BENZOATE
- SUCRALOSE
- XANTHAN GUM
- CITRIC ACID
- FD&C BLUE NO. 1
- ACETAMINOPHEN
- SORBITOL SOLUTION
- MENTHOL
- GLYCERIN
- WATER
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 84379-444 | 84379-444-12, 84379-444-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| CITRIC ACID | 2968PHW8QP | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| MENTHOL | L7T10EIP3A | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | 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 |
|---|---|---|---|---|---|---|
| XL-3 Night Time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Rnv LLC | 03210929-331e-462d-b566-4e1865f52246 | 2026-01-27 | Warnings | 84379-444-12 84379-444-06 84379-444 84379044412 84379044406 49634dc2-a45b-f42b-e063-6294a90ade9c 03210929-331e-462d-b566-4e1865f52246 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

