SANATOS TURBO MAX STRENGTH- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

SanaTos Turbo by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredients & Purposes

• Active ingredient (in each 20 mL): Purpose
• Dextromethorphan HBr 20 mg...................:

  Cough suppressant

• Guaifenesin 400 mg...................................:

  Expectorant

• Phenylephrine HCl 10 mg ………….......…: Nasal decongestant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
• temporarily relieves common cold/flu symptoms:
• cough due to minor throat and bronchial irritationnasal congestion due to hay fever
• other upper respiratory allergies
• sinus congestion and pressure
• stuffy nose

Warnings

Do not use

• for children under 12 years of age
• 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 two 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

• heart disease
• thyroid disease
• diabetes
• high blood pressure
• a cough that occurs with too much phlegm (mucus)
• a persistent or chronic cough such occurs with smoking, asthma or emphysema
• trouble urinating due to an enlarged prostate gland

When using this product

• do not use more than directed

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occur
• a persistent cough or symptoms do not get better within 7 days
• cough comes back, or occurs with a fever, rash or persistent headache. 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 overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not exceed recommended dosage
• use dosage cup
• mL = milliliter
• do not take more than 6 doses in any 24-hour period

• Age: Dose
• adults & children 12 years and older: 20 mL every 4 hours
• children under 12 years of age: do not use

Other information

Inactive ingredients

anhydrous citric acid, dextrose, D&C red # 33, FD&C red #40, flavors, glycerin, maltitol, propylene glycol, saccharin sodium, sodium benzoate, sucralose, xanthan gum, water

Questions or comments?

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

* This product is not manufactured or distributed by Reckitt Benckiser Inc., distributor of Mucinex® FAST-MAXTM Severe Congestion & Cough

PACKAGE PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SANATOS TURBO  MAX STRENGTH
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-322
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYL GALLATE (UNII: 8D4SNN7V92)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C RED NO. 40 (UNII: WZB9127XOA)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-322-06	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/03/2020

Labeler - Pharmadel LLC (030129680)