Pediacare ®

Pediacare ®
SPL v2
SPL
SPL Set ID 9576723b-748c-45e7-bc0d-cc109b9f6735
Route
ORAL
Published
Effective Date 2022-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (5 mg) Guaifenesin (100 mg)
Inactive Ingredients
Acesulfame Potassium Citric Acid Monohydrate Glycerin Menthol, Unspecified Form Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Water Sodium Benzoate Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-03

Description

Drug Facts


Medication Information

Description

Drug Facts

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 bronchial tubes
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. These could be signs of a serious condition.

Section 50570-1

Do not useif 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 drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1
Active ingredients (in each 5 mL) Purposes
Dextromethorphan HBr, USP 5 mg Cough suppressant
Guaifenesin, USP 100 mg Expectorant
Directions
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL=milliliter
AGE DOSE
children under 4 years do not use
children 4 to under 6 years 5 mL every 4 hours
children 6 to under 12 years 10 mL every 4 hours
adults and children 12 years and over 20 mL every 4 hours
Other Information
  • store at 20-25°C (68-77°F)
  • do not refrigerate
  • alcohol-free
Inactive Ingredients

acesulfame potassium, citric acid anhydrous, glycerin, flavor, menthol, polyethylene glycol, povidone, propylene glycol, purified water, sodium benzoate, sodium saccharin

Ask A Doctor Before Use If You Have
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Principal Display Panel 118 Ml Bottle Carton

Fast Acting

Pedia

Care ®

100% dedicated

to kids™

4 Years & Up

COUGH &

CONGESTION

Relieves:

  • Congestion & Mucus
  • Cough

Dextromethorphan HBr, USP (5 mg per 5 mL)

Guaifenesin, USP (100 mg per 5 mL)

Non-Drowsy

Grape Flavor

4 FL OZ (118 mL)


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 bronchial tubes
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache. These could be signs of a serious condition.

Section 50570-1 (50570-1)

Do not useif 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 drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredients (in each 5 mL) Purposes
Dextromethorphan HBr, USP 5 mg Cough suppressant
Guaifenesin, USP 100 mg Expectorant
Directions
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL=milliliter
AGE DOSE
children under 4 years do not use
children 4 to under 6 years 5 mL every 4 hours
children 6 to under 12 years 10 mL every 4 hours
adults and children 12 years and over 20 mL every 4 hours
Other Information (Other information)
  • store at 20-25°C (68-77°F)
  • do not refrigerate
  • alcohol-free
Inactive Ingredients (Inactive ingredients)

acesulfame potassium, citric acid anhydrous, glycerin, flavor, menthol, polyethylene glycol, povidone, propylene glycol, purified water, sodium benzoate, sodium saccharin

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Principal Display Panel 118 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton)

Fast Acting

Pedia

Care ®

100% dedicated

to kids™

4 Years & Up

COUGH &

CONGESTION

Relieves:

  • Congestion & Mucus
  • Cough

Dextromethorphan HBr, USP (5 mg per 5 mL)

Guaifenesin, USP (100 mg per 5 mL)

Non-Drowsy

Grape Flavor

4 FL OZ (118 mL)


Advanced Ingredient Data


Raw Label Data

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