Indications and uses
Temporarily relieves cough-cold symptoms cough due to minor throat and bronchial irritation headache minor aches and pains nasal congestion sinus congestion and pressure stuffy nose temporarily reduces fever
Sanatos
- Manufacturer
- Pharmadel LLC
- Effective date
- 2025-08-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- monthly-update
- Hydrated at
- 2026-06-03 17:45:55
Label at a glance#
ProductSanatos Daytime
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
do not exceed 4 doses in a 24 hour period Age Dose adults and children 12 years and older 2 softgels every 6 hours children 4 to under 12 years consult 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#
Active ingredients and Purposes
OTC - PURPOSE SECTION
| Active ingredients (in each softgel) | Purposes |
| Acetaminophen 325 mg .................... | Pain reliever/ fever reducer |
| Dextromethorphan HBr 10 mg ......... | Cough suppressant |
| Phenylephrine HCl 5 mg .................. | Nasal decongestant |
Uses
Temporarily relieves cough-cold symptoms
- cough due to minor throat and bronchial irritation
- headache
- minor aches and pains
- nasal congestion
- sinus congestion and pressure
- stuffy nose
- 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
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily 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.
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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- a cough that is accompanied by excessive phlegm (mucus)
- a persistent or chronic cough as occurs with smoking, asthma or emphysema
- difficulty urinating due to enlargement of the prostate gland
When using this product
do not exceed recommended dosage
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, cough or nasal congestions gets worse or lasts more than 7 days
- 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 accidental 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
- do not exceed 4 doses in a 24 hour period
| Age | Dose |
| adults and children 12 years and older | 2 softgels every 6 hours |
| children 4 to under 12 years | consult a doctor |
| children under 4 years | do not use |
Other information
- store between 68-77°F (20-25°C)
- avoid excessive heat
- do not use if blister pack unit is punctured or torn
Inactive ingredients
FD&C red #40, FD&C yellow #6, gelatin, glycerin, methylparaben, polyethylene glycol 400, povidone k-30, propylene glycol, propylparaben, sorbitol, titanium dioxide, water.
Questions or comments?
+1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com
Distributed by:
Distributed by:
PHARMADEL LLC
New Castle, DE, 19720
/PHARMADELUSA
Principal Display Panel
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- Sanatos Daytime
- Acetaminophen, Dextromethorphan, Phenylephrine
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- GELATIN
- GLYCERIN
- POLYETHYLENE GLYCOL 400
- POVIDONE K30
- PROPYLENE GLYCOL
- WATER
- SORBITOL
- METHYLPARABEN
- PROPYLPARABEN
- TITANIUM DIOXIDE
- ACETAMINOPHEN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55758-041 | 55758-041-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIM |
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 |
|---|---|---|---|---|---|---|
| 3c1cc3b0-f87b-98d2-e063-6394a90a6c98 | 22f580a2-253b-df5c-e063-6394a90a75ba | 2025-08-11 | Warnings | 3c1cc3b0-f87b-98d2-e063-6394a90a6c98 22f580a2-253b-df5c-e063-6394a90a75ba |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.