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

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]

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

corn starch, microcrystalline cellulose, povidone-iodine, povidone k30, silicone dioxide, stearic acid, talc

Questions & comments?

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

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INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-361
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 K30 (UNII: U725QWY32X)
TALC (UNII: 7SEV7J4R1U)
STARCH, CORN (UNII: O8232NY3SJ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE-IODINE (UNII: 85H0HZU99M)

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	OVAL	Size	17mm
Flavor		Imprint Code	A12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-361-02	2 in 1 PACKET; Type 0: Not a Combination Product	08/01/2020
2	NDC: 55758-361-99	50 in 1 CARTON	08/01/2020
2	NDC: 55758-361-02	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

Labeler - Pharmadel LLC (030129680)