SanaTos Multi Symptom by Pharmadel LLC SanaTos MS Display 2x50

SanaTos Multi Symptom by

Drug Labeling and Warnings

SanaTos Multi Symptom by is a Otc medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SANATOS MULTI SYMPTOM- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci tablet 
Pharmadel LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SanaTos MS Display 2x50

Drug Facts

Active Ingredient & Purposes

• Active ingredients (in each tablet): Purposes
• Acetaminophen 325 mg: Pain reliever/ fever reducer
• Dextromethorphan HBr 15 mg: Cough suppressant
• Guaifenesin 200 mg:

  Expectorant

• Phenylephrine HCI 5 mg: Nasal decongestant

Uses

Temporarily relieves common cold/flu symptoms:

• minor aches & pains
• headache
• sore throat
• nasal congestion due to hay fever
• sinus congestion
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
• temporarily reduces fever

Warnings

Liver Warning:

This product contains acetaminophen. Severe liver damage may occur if you take

• more than 8 tablets 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 skine 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 vomitting, consult a doctor promptly.

Do not use

• with any 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, asl a doctor or pharmacist before taking this product.
• for more than 7 days for pain and 3 days or fever, unless directed by a doctor.

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• throid disease
• diabetes
• trouble urinating due to enlarged prostate gland
• a cough that is accompained by excessive phlegm (mucus)
• a persistant or chronic cough such as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

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 recommended dosage
• adults and children 12 years of age and over:
• take 2 tablets every 6-8 hours; do not exceed 8 tablets in a 24-hour period
• children under 12 years of age: consult a doctor

Other information

• store at room temperature 59-86F (15-30C)
• avoid excessive heat and humidity

TAMPER EVIDENCE: Do not use if packet is open or torn.

Inactive ingredients

maltodextrin, microcrystalline cellulose, povidone, silicon dioxide*, sodium starch glycolate, starch, stearic acid

*may contain

Questions & comments?

+1-866-359-3478 (M-F) 9AM to 5 PM EST or www.pharmadel.com

SANATOS MULTI SYMPTOM 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-302
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
STARCH, CORN (UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	ROUND	Size	12mm
Flavor		Imprint Code	FR12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-302-01	2 in 1 PACKET; Type 0: Not a Combination Product	08/01/2020	12/31/2022
2	NDC: 55758-302-50	50 in 1 CARTON	08/01/2020	12/31/2022
2	NDC: 55758-302-01	2 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/01/2020	12/31/2022

Labeler - Pharmadel LLC (030129680)

Revised: 5/2022

Document Id: df75f3b2-9a6f-dfb8-e053-2a95a90a04a0

34390-5

Set id: ad6408ff-079b-4757-e053-2995a90a53eb

Version: 6

Effective Time: 20220520