Indications and uses
Temporarily relieves common cold/flu symptoms: minor aches and pains sore throat headache nasal congestion runny nose itchy nose and throat cough due to minor throat & bronchial irritation and temporarily reduces fever
SanaTos
- Manufacturer
- Pharmadel LLC
- Effective date
- 2026-01-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- full-release
- Hydrated at
- 2026-06-01 01:32:59
Label at a glance#
ProductSanaTos Severe Cold Relief Nighttime
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN
Label structure10 sections
Dosage and administration
dissolve one packet in an 8 fl oz glass of hot water. If using a microwave; add content into a glass of cool water and stir briskly before and after heating. Do not overheat. Sip while hot and consume the entire drink within 10-15 minutes adults and children 12 years of age and older: one (1) packet every 4 hours, do not exceed 6 packets per 24 hours children under 12 years of age: do not use
Storage and handling
each packet contains: potassium 10 mg, sodium 27 mg phenylketonurics: contains phenylalanine 13 mg per packet store at room temperature 68-77°F (20-25°C) do not use if packets are punctured or torn.
Contacts and useful links#
Websitewww.pharmadel.com
www.pharmadel.com
www.pharmadel.comLabel contents#
Full prescribing information#
Drug Facts
Drug Facts
Active ingredients & Purposes
OTC - PURPOSE SECTION
| Active Ingredients (in each packet) | Purposes |
|---|---|
| Acetaminophen 650 mg | Pain reliever/ fever reducer |
| Diphenhydramine HCL 25 mg | Antihistamine/ cough suppressant |
| Phenylephrine HCL 10 mg | Nasal decongestant |
Uses
Temporarily relieves common cold/flu symptoms:
- minor aches and pains
- sore throat
- headache
- nasal congestion
- runny nose
- itchy nose and throat
- cough due to minor throat & bronchial irritation
- and temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 doses 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.
- with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you
- have liver disease
- have heart disease
- have high blood pressure
- have thyroid disease
- have diabetes
- have glaucoma
- have a breathing problem such as emphysema
- have difficulty urinating due to an enlarged prostate gland
- have a breathing problem such as emphysema or chronic bronchitis
- are taking sedatives or tranquilizers
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
When using this product
- do not exceed recommended dosage
- may cause excitability, especially in children
- use caution when driving a motor vehicle or operating machinery
- may cause marked drowsiness
Stop use and ask doctor if
- nervousness, dizziness, or sleeplessness occur
- redness or swelling is present
- pain, cough, or nasal congestion persists or gets worse or last more than 7 days
- fever gets worse or lasts more than 3 days
- 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.
Kepp 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
- dissolve one packet in an 8 fl oz glass of hot water. If using a microwave; add content into a glass of cool water and stir briskly before and after heating. Do not overheat.
- Sip while hot and consume the entire drink within 10-15 minutes
- adults and children 12 years of age and older: one (1) packet every 4 hours, do not exceed 6 packets per 24 hours
- children under 12 years of age: do not use
Other information
- each packet contains: potassium 10 mg, sodium 27 mg
- phenylketonurics: contains phenylalanine 13 mg per packet
- store at room temperature 68-77°F (20-25°C)
- do not use if packets are punctured or torn.
Inactive ingredients
acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow #10, eucalyptus honey lemon flavors, FD&C blue #1, FD&C red #40, isopropyl alcohol, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate, water
Questions?
+1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com
Distributed by:
PHARMADEL LC
New Castle, DE 19720
Made in India
PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1659960 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution | PSN | 8 |
| 1659960 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution | SCD | 8 |
| 1659960 | acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral Solution | SY | 8 |
| 1659960 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution | SY | 8 |
| 1659960 | APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution | SY | 8 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | 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 |
|---|---|---|---|---|---|---|
| 55758-385-06 | SanaTosSevere Cold Relief Nighttime | 6 in 1 CARTON | GRANULE, FOR SOLUTION | 6 | 8 |
Products#
Every source-derived product name is available through these pages.
- SanaTos Severe Cold Relief Nighttime
- Acetaminophen, Diphenhydramine hydrochloride, and Phenylephrine hydrochloride
- ISOPROPYL ALCOHOL
- WATER
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ACESULFAME POTASSIUM
- ASPARTAME
- ANHYDROUS CITRIC ACID
- D&C YELLOW NO. 10
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- MALTODEXTRIN
- SILICON DIOXIDE
- SODIUM CITRATE
- SUCROSE
- TRIBASIC CALCIUM PHOSPHATE
- ACETAMINOPHEN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55758-385 | 55758-385-06 |
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 Severe Cold Relief Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Pharmadel LLC | 144aafcc-6ec2-a322-e063-6294a90afc27 | 2026-01-15 | Warnings | 55758-385-06 55758-385 55758038506 4873c00c-3edf-844a-e063-6394a90ac80d 144aafcc-6ec2-a322-e063-6294a90afc27 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.