SANATOS TURBO MAX STRENGTH- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid 
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 Turbo MS (Apta)

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

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

AgeDose
adults & children 12 years and older20 mL every 4 hours
children under 12 years of agedo 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

PDP Turbo Max

SANATOS TURBO  MAX STRENGTH
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-322
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-322-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/03/2020
Labeler - Pharmadel LLC (030129680)

Revised: 1/2022
Document Id: d56a071c-a748-5397-e053-2995a90aad8b
Set id: d56a071c-a747-5397-e053-2995a90aad8b
Version: 1
Effective Time: 20220112
 
Pharmadel LLC