Indications and uses
temporarily relieves common cold/flu symptoms: minor aches & pains headache sore throat fever nasal congestion cough due to minor throat and bronchial irritation
Sanatos Multi Symptom Daytime
- Manufacturer
- Pharmadel LLC
- Effective date
- 2023-11-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:02:38
Label at a glance#
ProductSanatos Multi Symptom Daytime
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN
Label structure9 sections
Dosage and administration
take only as recommended (see overdose warning) use a dosage cup or tablespoon (TBSP) do not exceed 4 doses per 24 hrs age dose adults & children 12 years & over 30 mL (2 TBSP) every 4 hours children 6 years to under 12 years 15 mL (1 b TBSP) every 4 hours children 4 years to under 6 years ask a doctor children under 4 years do not use when using daytime and nighttime products, carefully read each label to ensure ...
Contacts and useful links#
Websitewww.sanatos.com
www.sanatos.com
www.sanatos.comLabel contents#
Full prescribing information#
Active Ingredients & Purposes
OTC - PURPOSE SECTION
Active ingredients (in each 15 mL, 1 tablespoon) | Purposes |
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Phenylephrine HCI 5 mg | Nasal decongestant |
Uses
temporarily relieves common cold/flu symptoms:
- minor aches & pains
- headache
- sore throat
- fever
- nasal congestion
- cough due to minor throat and bronchial irritation
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adults take more than 4,000 mg if acetaminophen in 24 hours
- child take more than 5 doses in 24 hours
- 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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
- 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.
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if you have
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- trouble urinating due to enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough that occurs with too much phlegm (mucus)
When using this product
- do not use more than directed (see overdose warning)
- avoid alcoholic drinks
Stop use and ask a doctor if
- you get nervos, dizzy or sleepless
- new symptoms occur
- fever gets worse or lasts more than 3 days
- pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
- redness or swelling is present
- 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 this and all drugs out of reach of children.
Overdose warning:
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
- take only as recommended (see overdose warning)
- use a dosage cup or tablespoon (TBSP)
- do not exceed 4 doses per 24 hrs
| age | dose |
| adults & children 12 years & over | 30 mL (2 TBSP) every 4 hours |
| children 6 years to under 12 years | 15 mL (1 b TBSP) every 4 hours |
| children 4 years to under 6 years | ask a doctor |
| children under 4 years | do not use |
- when using daytime and nighttime products, carefully read each label to ensure correct dosing.
Other information
- sodium content per tablespoon: 10 mg
- store at room temperature
TAMPER EVIDENT: Do not use if imprinted band is missing or broken.
Inactive ingredients
citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purfied water, saccarhin sodium, sodium benzoate, sucrose
Questions?
call 1-866-359-3478
Distributed by:
Principal Display Panel
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 1 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 1 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 1 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 1 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55758-055-06 | Sanatos Multi Symptom Daytime | 177 mL in 1 BOTTLE, PLASTIC | LIQUID | 177 | 1 | |
| 55758-055-25 | Sanatos Multi Symptom Daytime | 177 mL in 1 BOTTLE, PLASTIC | LIQUID | 177 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Sanatos Multi Symptom Daytime
- Acetaminophen, Dextromethorphan HBr, Phenylephrine HCI
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- ANHYDROUS CITRIC ACID
- WATER
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- FD&C YELLOW NO. 6
- FOOD YELLOW 3 FREE ACID
- GLYCERIN
- SUCROSE
- ACETAMINOPHEN
- PROPYLENE GLYCOL
- SODIUM BENZOATE
- SACCHARIN SODIUM
- SACCHARIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55758-055 | 55758-055-06, 55758-055-25 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| WATER | 059QF0KO0R | IACT |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SUCROSE | C151H8M554 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | 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 |
|---|---|---|---|---|---|---|
| Sanatos Multi Symptom Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI | Pharmadel LLC | 0ab11691-5b29-55fc-e063-6394a90aa328 | 2023-11-17 | Warnings | 55758-055-06 55758-055-25 55758-055 55758005506 55758005525 0ab11691-5b2a-55fc-e063-6394a90aa328 0ab11691-5b29-55fc-e063-6394a90aa328 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.