Sanatos Turbo Ms (apta)

Sanatos Turbo Ms (apta)
SPL v2
SPL
SPL Set ID d56a071c-a747-5397-e053-2995a90aad8b
Route
ORAL
Published
Effective Date 2020-09-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (10 mg) Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
Propyl Gallate Fd&c Blue No. 1 Water Anhydrous Citric Acid Sorbitol Glycerin Fd&c Red No. 40 Edetate Disodium Propylene Glycol Sucralose Sodium Benzoate Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-09-03

Description

Active ingredient (in each 20 mL) Purpose Dextromethorphan HBr 20 mg................... Cough suppressant Guaifenesin 400 mg................................... Expectorant Phenylephrine HCl 10 mg ………….......… Nasal decongestant


Medication Information

Description

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
Section 55105-1
Active ingredient (in each 20 mL) Purpose
Dextromethorphan HBr 20 mg...................

Cough suppressant

Guaifenesin 400 mg...................................

Expectorant

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

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

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.
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

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.

Package Principal Display Panel

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

Structured Label Content

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
Section 55105-1 (55105-1)
Active ingredient (in each 20 mL) Purpose
Dextromethorphan HBr 20 mg...................

Cough suppressant

Guaifenesin 400 mg...................................

Expectorant

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

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

Do Not Use (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.
Inactive Ingredients (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? (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

When Using This Product (When using this product)
  • do not use more than directed
Stop Use and Ask A Doctor If (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, (If pregnant or breast feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Package Principal Display Panel (PACKAGE PRINCIPAL DISPLAY PANEL)

Ask A Doctor Before Use If You Have (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

Advanced Ingredient Data


Raw Label Data

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