Indications and uses
temporarily relieves these common cold/flu symptoms: sore throat headache minor aches and pains fever runny nose and sneezing cough due to minor throat and bronchial irritation
Sanatos Nighttime Multi Symptoms
- Manufacturer
- Pharmadel LLC
- Effective date
- 2019-12-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:54:29
Label at a glance#
ProductSanatos Nighttime Multi Symptoms
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, ACETAMINOPHEN
Label structure9 sections
Dosage and administration
take only as recommended - see Overdose warning use dose cup or tablespoon (TBSP) do not exceed 4 doses per 24 hours age dose adults & children 12 years & over 30 mL(2TBSP) every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use If taking Nighttime at night and Daytime during the day, limit total to 4 doses per 24 hours.
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 30 mL dose cup) | Purposes |
| Acetaminophen 650 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 30 mg | Cough suppressant |
| Doxylamine succinate 12 mg | Antihistamine |
Uses
temporarily relieves these common cold/flu symptoms:
- sore throat
- headache
- minor aches and pains
- fever
- runny nose and sneezing
- cough due to minor throat and bronchial irritation
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks everyday 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.
- to make a child sleepy
Ask a doctor before use if you have
- a sodium-restricted diet
- liver disease
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- trouble urinating due to enlarged prostate gland
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product
- do not use more than directed
- avoid alcoholic drinks
- excitability may occur, especially in children
- marked drowsiness may occur
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
Stop use and ask a doctor if
- redness or swelling is present
- symptoms do not get better within 7 days or are accompanied by fever
- fever gets worse or lasts more than 3 days
- cough lasts more than 7 days, comes back, or occurs with fever, 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.
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 dose cup or tablespoon (TBSP)
- do not exceed 4 doses per 24 hours
| age | dose |
| adults & children 12 years & over | 30 mL(2TBSP) every 6 hours |
| children 4 to under 12 years | ask a doctor |
| children under 4 years | do not use |
- If taking Nighttime at night and Daytime during the day, limit total to 4 doses per 24 hours.
Other informaiton
- each 30 mL dose cup contains: sodium 45 mg
- store at room temperature
Tamper Evident: Do not use if imprinted shrink band is missing or broken.
Inactive ingredients
citric acid, D&C yellow#10, FD&C Green# 3, FD&C yellow# 6, flavor, glycerin, polythylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose
Questions?
call 1-866-359-3478
Distributed by:
Princpal Display Panel
Alcohol- Free / Original Flavor
SanaTos®
Nighttime
MULTI-SYMPTOMS COLD
& FLU RELIEF
Acetaminophen,
Dextromethorphan HBr, Doxylamine Succinate
- Minor Aches & Pains, Fever
- Sore Throat
- Sneezing, Runny Nose
- Cough
NEW & IMPROVED
6 FL OZ (177 mL)
Products#
Every source-derived product name is available through these pages.
- Sanatos Nighttime Multi Symptoms
- Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
- SUCROSE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- WATER
- DOXYLAMINE SUCCINATE
- DOXYLAMINE
- ANHYDROUS CITRIC ACID
- FD&C GREEN NO. 3
- FD&C YELLOW NO. 6
- FOOD YELLOW 3 FREE ACID
- SACCHARIN SODIUM
- SACCHARIN
- SODIUM BENZOATE
- SODIUM CITRATE
- ACETAMINOPHEN
- D&C YELLOW NO. 10
- GLYCERIN
- PROPYLENE GLYCOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55758-023 | 55758-023-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SUCROSE | C151H8M554 | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| WATER | 059QF0KO0R | IACT |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| FD&C GREEN NO. 3 | 3P3ONR6O1S | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | 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 |
|---|---|---|---|---|---|---|
| 0abf7def-2771-6a94-e063-6394a90a9cd3 | 6052e596-3f4f-043b-e053-2a91aa0a053f | 2023-11-22 | Warnings | 6052e596-3f4f-043b-e053-2a91aa0a053f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.