Pediacare ®

Pediacare ®
SPL v2
SPL
SPL Set ID fabafdc1-9dd8-4258-af49-bab1e29ad109
Route
ORAL
Published
Effective Date 2022-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Brompheniramine (2 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)
Inactive Ingredients
Citric Acid Monohydrate Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose

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 occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves these symptoms due to hay fever (allergic rhinitis):
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • temporarily restores freer breathing through the nose
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 53414-9

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

Section 55105-1
Active ingredients (in each 10 ml) Purposes
Brompheniramine maleate, USP 2 mg Antihistamine
Dextromethorphan HBr, USP 10 mg Cough Suppressant
Phenylephrine HCl, USP 5 mg Nasal decongestant
Directions
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosage cup provided
  • keep dosing cup with product
  • mL = milliliter
age dose
adults and children 12 years and over 20 mL every 4 hours
children 6 to under 12 years 10 mL every 4 hours
children under 6 years do not use
Do Not Use
  • to sedate a child or to make a child sleepy
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certaindrugs 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.
Other Information
  • store at 20-25°C (68-77°F)
Inactive Ingredients

citric acid anhydrous, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

When Using This Product
  • do not use more than directed
  • may cause marked drowsiness
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Stop Use and Ask A Doctor If
  • you get nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days or are accompanied by fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a cough that occurs with too much phlegm (mucus)
  • a breathing problem or persistent or chronic cough that lasts 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™

6 Years & Up

COUGH & COLD

Relieves:

  • Stuffy, Runny Nose
  • Itchy, Watery Eyes
  • Sneezing
  • Cough

Brompheniramine maleate - Antihistamine

(2 mg per 10 mL)

Phenylephrine HCl - Nasal decongestant

(5 mg per 10 mL)

Dextromethorphan HBr - Cough suppressant

(10 mg per 10 mL)

Alcohol Free

Grape Flavor

4 FL OZ (118 mL)

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking any other oral nasal decongestant or stimulant
  • taking sedatives or tranquilizers

Structured Label Content

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves these symptoms due to hay fever (allergic rhinitis):
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • temporarily restores freer breathing through the nose
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 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients (in each 10 ml) Purposes
Brompheniramine maleate, USP 2 mg Antihistamine
Dextromethorphan HBr, USP 10 mg Cough Suppressant
Phenylephrine HCl, USP 5 mg Nasal decongestant
Directions
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosage cup provided
  • keep dosing cup with product
  • mL = milliliter
age dose
adults and children 12 years and over 20 mL every 4 hours
children 6 to under 12 years 10 mL every 4 hours
children under 6 years do not use
Do Not Use (Do not use)
  • to sedate a child or to make a child sleepy
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certaindrugs 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.
Other Information (Other information)
  • store at 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

citric acid anhydrous, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

When Using This Product (When using this product)
  • do not use more than directed
  • may cause marked drowsiness
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you get nervous, dizzy, or sleepless
  • symptoms do not get better within 7 days or are accompanied by fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a cough that occurs with too much phlegm (mucus)
  • a breathing problem or persistent or chronic cough that lasts 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™

6 Years & Up

COUGH & COLD

Relieves:

  • Stuffy, Runny Nose
  • Itchy, Watery Eyes
  • Sneezing
  • Cough

Brompheniramine maleate - Antihistamine

(2 mg per 10 mL)

Phenylephrine HCl - Nasal decongestant

(5 mg per 10 mL)

Dextromethorphan HBr - Cough suppressant

(10 mg per 10 mL)

Alcohol Free

Grape Flavor

4 FL OZ (118 mL)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking any other oral nasal decongestant or stimulant
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

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