Indications and uses
Temporarily relieves the common cold/flu symptoms associated with minor aches and pains headache sore throat runny nose cough due to minor throat and bronchial irritation sneezing temporarily reduces fever
Sanatos Nighttime Relief - Pharmadel LLC
- Manufacturer
- Pharmadel LLC
- Effective date
- 2026-04-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:52:14
Label at a glance#
ProductSanatos Nighttime Relief
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure10 sections
Dosage and administration
if you are taking other cold/flu products, read complete labeling before dosing Age Dose adults and children 12 years and older two (2) softgels every 6 hours, do not exceed 8 softgels in 24 hours children 4 to under 12 years ask a doctor children under 4 years do not use
Contacts and useful links#
Websitewww.pharmadel.com
www.pharmadel.com
www.pharmadel.comLabel contents#
Full prescribing information#
Drug Facts
.
Active ingredients and Purposes
.
Purposes
Active ingredients(in each softgel) Purpose
Acetaminophen 325mg ...........................................................Pain reliever/ fever reducer
Dextromethorphan HBr 20mg....................................................Cough suppressant
Doxylamine succinate 12.5mg.................................................... Antihistamine
Uses
Temporarily relieves the common cold/flu symptoms associated with
- minor aches and pains
- headache
- sore throat
- runny nose
- cough due to minor throat and bronchial irritation
- sneezing
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 softgels in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 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, 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.
Ask a doctor before use if you have
- liver disease
- glaucoma
- a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- a cough that is accompanied by excessive phlegm (mucus)
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- excitability may occur, especially in children
- marked drowsiness may occur
- alcoholic, sedatives, and tranquillizers may increase drowsiness
- avoid alcoholic beverages
- use caution 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
- any new symptoms occur
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- if you are taking other cold/flu products, read complete labeling before dosing
| Age | Dose |
| adults and children 12 years and older | two (2) softgels every 6 hours, do not exceed 8 softgels in 24 hours |
| children 4 to under 12 years | ask a doctor |
| children under 4 years | do not use |
Other information
- store between 68-77°F (20-25°C)
- avoid excess heat
Inactive ingredients
D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
Questions?
+1-866-359-3478 (M-F) 9AM – 5PM EST or www.pharmadel.com
Dist. by/ por:
Pharmadel LLC
New Castle, DE 19947
+1-866-359-3478
†This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® Nyquil® Liquicap
Principal Display Panel
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2739790 | acetaminophen 325 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG Oral Capsule | PSN | 1 |
| 2739790 | acetaminophen 325 MG / dextromethorphan hydrobromide 20 MG / doxylamine succinate 12.5 MG Oral Capsule | SCD | 1 |
| 2739790 | acetaminophen 325 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG Oral Capsule | SY | 1 |
| 2739790 | APAP 325 MG / dextromethorphan hydrobromide 20 MG / doxylamine succinate 12.5 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#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55758-515-08 | Sanatos Nighttime Relief | 8 in 1 CARTON | CAPSULE, LIQUID FILLED | 8 | 1 | |
| 55758-515-08 | Sanatos Nighttime Relief | 2 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 2 | 1 |
Products#
Every source-derived product name is available through these pages.
- Sanatos Nighttime Relief
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
- D&C YELLOW NO. 10
- FD&C BLUE NO. 1
- GELATIN, UNSPECIFIED
- GLYCERIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- PROPYLENE GLYCOL
- WATER
- SORBITOL SOLUTION
- SORBITAN
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55758-515 | 55758-515-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| Sanatos Nighttime Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Pharmadel LLC | 4c26c8bf-0143-ddca-e063-6294a90a3552 | 2026-04-01 | Warnings | 55758-515-08 55758-515 55758051508 4c26c8bf-0144-ddca-e063-6294a90a3552 4c26c8bf-0143-ddca-e063-6294a90a3552 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.