Santos Toddler Mucus (ap/ Ple)

Santos Toddler Mucus (ap/ Ple)
SPL v6
SPL
SPL Set ID 60672feb-1421-651e-e053-2a91aa0af41d
Route
ORAL
Published
Effective Date 2025-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (50 mg) Dextromethorphan (2.5 mg)
Inactive Ingredients
Sorbitol Solution Sodium Benzoate Anhydrous Citric Acid Glycerin Propylene Glycol Water D&c Red No. 33 Fd&c Red No. 40 Xanthan Gum Sucralose

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-10-17

Description

Active ingredients (in each 2.5 mL) Purposes Dextromethorphan HBr 2.5 mg ..... Cough suppressant Guaifenesin 50 mg............ Expectorant


Medication Information

Description

Active ingredients (in each 2.5 mL) Purposes Dextromethorphan HBr 2.5 mg ..... Cough suppressant Guaifenesin 50 mg............ Expectorant

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain the bronchial tubes
Section 55105-1
Active ingredients (in each 2.5 mL) Purposes
Dextromethorphan HBr 2.5 mg .....

Cough suppressant

Guaifenesin 50 mg............ Expectorant

Directions
  • do not give a child more than 6 doses in 24 hour period
  • repeat the dose every 4 hours
  • use only included oral syringe to measure dose

Age Dose
children 2 to under 6 years of age 2.5 mL every 4 hours
children under 2 years of age consult a doctor



Do Not Use

in a child who is 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 drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Questions?

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

Distributed by / Distribuido por:

PHARMADEL LLC

New Castle, DE 19720

Other Information

■ store between 68-77°F (20-25°C)

■ do not refrigerate

■ keep carton for full direction for use

Inactive Ingredients

anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, propylene glycol, sodium benzoate, sorbitol solution, sucralose, xanthan gum, water

Principal Display Panel

When Using This Product

do not use more than directed

Keep Out of Reach of Children.

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

Ask A Doctor Before Use If the Child Has A
  • cough that is accompanied by excessive phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma
Stop Use and Ask A Doctor, If the Child Has A

cough that persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.


Structured Label Content

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain the bronchial tubes
Section 55105-1 (55105-1)
Active ingredients (in each 2.5 mL) Purposes
Dextromethorphan HBr 2.5 mg .....

Cough suppressant

Guaifenesin 50 mg............ Expectorant

Directions
  • do not give a child more than 6 doses in 24 hour period
  • repeat the dose every 4 hours
  • use only included oral syringe to measure dose

Age Dose
children 2 to under 6 years of age 2.5 mL every 4 hours
children under 2 years of age consult a doctor



Do Not Use (Do not use)

in a child who is 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 drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Questions?

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

Distributed by / Distribuido por:

PHARMADEL LLC

New Castle, DE 19720

Other Information (Other information)

■ store between 68-77°F (20-25°C)

■ do not refrigerate

■ keep carton for full direction for use

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, propylene glycol, sodium benzoate, sorbitol solution, sucralose, xanthan gum, water

Principal Display Panel

When Using This Product (When using this product)

do not use more than directed

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.

Ask A Doctor Before Use If the Child Has A (Ask a doctor before use if the child has a)
  • cough that is accompanied by excessive phlegm (mucus)
  • persistent or chronic cough such as occurs with asthma
Stop Use and Ask A Doctor, If the Child Has A (Stop use and ask a doctor, if the child has a)

cough that persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.


Advanced Ingredient Data


Raw Label Data

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