Indications and uses
Temporarily relieves common cold/flu symptoms associted with minor aches & pains headache sore throat fever cough due to minor throat and bronchial irritation
Sanatos
- Manufacturer
- Pharmadel LLC
- Effective date
- 2023-12-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:02:57
Label at a glance#
ProductSanatos Multi Symptom Daytime
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN
Label structure9 sections
Dosage and administration
use only dosing cup provided shake well before use if you are taking other cold/flu products, read complete labeling before dosing adults & children 12 years & over 30 mL every 4 hours, do not exceed (child) 4 doses and (adult) 6 doses per 24 hours children under 12 years of age do not use
Contacts and useful links#
Websitewww.pharmadel.com
www.pharmadel.com
www.pharmadel.comLabel contents#
Full prescribing information#
Active ingredients & Purposes
OTC - PURPOSE SECTION
Active ingredients (in each 30 mL) | Purposes |
| Acetaminophen 650 mg | Pain reliever/ fever reducer |
| Dextromethorphan HBr 20 mg | Cough suppressant |
Uses
Temporarily relieves common cold/flu symptoms associted with
- minor aches & pains
- headache
- sore throat
- fever
- 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 6 doses in 24 hours, which is the maxium daily amount
- child takes more than 4 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day 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
- 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 user
- has a sodium restricted diet
- has liver disease
- hastrouble urinating due to enlarged prostate gland
- haspersistent or chronic cough such as occurs with smoking, asthma, or emphysema
- has a cough that occurs with too much phlegm (mucus)
- is a child with pain of arthritis
Ask a doctor or pharmacist before use if the user is
- taking the blood thinning drug warfarin
Stop use and ask a doctor if
- pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
- 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.
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
- use only dosing cup provided
- shake well before use
- if you are taking other cold/flu products, read complete labeling before dosing
| adults & children 12 years & over | 30 mL every 4 hours, do not exceed (child) 4 doses and (adult) 6 doses per 24 hours |
| children under 12 years of age | do not use |
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 anhydrous, FD&C yellow #6, flavor, glycerin, menthol, propylene glycol, sodium benzoate, sorbitol solution, sodium citrate, sucralose, xanthan gum, water
Questions?
+1-866-359-3478 (M-F) 9AM – 5PM EST or www.pharmadel.com
Distributed by:
Prinicipal Display Panel
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2604561 | acetaminophen 650 MG / dextromethorphan HBr 20 MG in 30 mL Oral Solution | PSN | 1 |
| 2604561 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral Solution | SCD | 1 |
| 2604561 | acetaminophen 325 MG / dextromethorphan HBr 10 MG per 15 ML Oral Solution | SY | 1 |
| 2604561 | acetaminophen 650 MG / dextromethorphan HBr 20 MG per 30 ML Oral Solution | SY | 1 |
| 2604561 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral Solution | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55758-415-06 | SanatosMulti 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
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- ANHYDROUS CITRIC ACID
- WATER
- FD&C YELLOW NO. 6
- FOOD YELLOW 3 FREE ACID
- GLYCERIN
- ACETAMINOPHEN
- PROPYLENE GLYCOL
- SODIUM BENZOATE
- SUCRALOSE
- SORBITOL SOLUTION
- XANTHAN GUM
- MENTHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55758-415 | 55758-415-06 |
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 |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| MENTHOL | L7T10EIP3A | 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 | Pharmadel LLC | 0a5fc0ef-ba34-bb0b-e063-6394a90af7d9 | 2023-12-01 | Warnings | 55758-415-06 55758-415 55758041506 0a5fc0ef-ba33-bb0b-e063-6394a90af7d9 0a5fc0ef-ba34-bb0b-e063-6394a90af7d9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.