temporarily relieves these common cold/ flu symptoms: nasal congestion headache sore throat minor aches and pains cough due to minor throat and bronchial irritation temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
this product does not contain directions or complete warnings for adult use do not give more than directed (see Overdose warning) shake well before use children 6 to under 12 years of age: take 10 mL in dosing cup provided every 4 hours, while symptoms persist, up to 5 times a day or as directed by a doctor children under 6 years of age: do not use
each 10 mL contains: sodium 5 mg store between 59-86°F (15-30°C) do not refrigerate
www.pharmadel.com| Active ingredient (in each 10 mL) | Purposes |
| Acetaminophen 325 mg ..................................... | Pain reliever/ fever reducer |
| Dextromethorphan HBr 10 mg............................... | Cough suppressant |
| Guaifenesin 200 mg............................................... | Expectorant |
| Phenylephrine HCI 5 mg........................................ | Nasal decongestant |
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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, nausea, and vomiting, consult doctor promptly
aking the blood thinning drug warfarin.
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. Prompt medical attention is critical even if you do not notice any signs or symptoms.
anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
+1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1116572 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution | PSN | 1 |
| 1116572 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 1 |
| 1116572 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution | SY | 1 |
| 1116572 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution | SY | 1 |
| 1116572 | APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55758-443-04 | SanaTos X Children | 118 mL in 1 BOTTLE, PLASTIC | LIQUID | 118 | 1 | |
| 55758-443-04 | SanaTos X Children | 1 in 1 CARTON | LIQUID | 1 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55758-443 | 55758-443-04 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| PROPYL GALLATE | 8D4SNN7V92 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
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 X Children | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI | Pharmadel LLC | 1fc1408c-c540-39ab-e063-6394a90aa477 | 2024-08-15 | Warnings | 55758-443-04 55758-443 55758044304 1fc1408c-c541-39ab-e063-6394a90aa477 1fc1408c-c540-39ab-e063-6394a90aa477 |
Adverse event summaries are temporarily unavailable. Other product information remains available.