Children's

Children's
SPL v1
SPL
SPL Set ID 6fb0653e-02a2-4077-8a7d-be02d246b1c2
Route
ORAL
Published
Effective Date 2009-11-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Brompheniramine (0.5 mg) Dextromethorphan (5 mg) Phenylephrine (1.25 mg)
Inactive Ingredients
Grape Citric Acid Monohydrate Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Water Sodium Benzoate Sodium Citrate Saccharin Sodium Sorbitol

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH FINAL Active Since 2009-11-04

Description

RUNNY NOSE & COUGH Drug Facts


Medication Information

Description

RUNNY NOSE & COUGH 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

RUNNY NOSE & COUGH

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 50568-5

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

Section 53414-9

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

Section 55105-1
Active ingredients

(in each 5 mL tsp)
Purposes
Brompheniramine maleate, USP .5 mg Antihistamine
Dextromethorphan HBr, USP 5 mg Cough suppressant
Phenylephrine HCl, USP 1.25 mg Nasal decongestant
Directions
  • do not take more than 4 doses in any 24-hour period
  • to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age
  • specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device
age dose
children 6 to under 12 years 1½-3 tsp. (7.5-15 mL) every 6 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) (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.
Questions?

877-434-2036

Other Information
  • each teaspoon contains: sodium 3 mg
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients

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

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.
Principal Display Panel 118 Ml Carton

CHILDREN'S

ACCUDIAL

ROTATING DOSING LABEL

ACCURATE DOSING

BY WEIGHT

Nasal Decongestant

Antihistamine

Cough Suppressant

RELIEVES

Nasal Congestion

Runny Nose

Itchy, Watery Eyes

Coughing, Sneezing

For Ages 6 to under 12

Alcohol Free

Compares to the

active ingredients in

Children's Dimetapp®

Cold & Cough.

GRAPE

FLAVOR

4 FL. OZ.

(118 mL)

NDC 45014-153-04

Runny Nose & Cough

Ask A Doctor Before Use If the Child Has
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • 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

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)

RUNNY NOSE & COUGH

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 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

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 tsp)
Purposes
Brompheniramine maleate, USP .5 mg Antihistamine
Dextromethorphan HBr, USP 5 mg Cough suppressant
Phenylephrine HCl, USP 1.25 mg Nasal decongestant
Directions
  • do not take more than 4 doses in any 24-hour period
  • to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age
  • specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device
age dose
children 6 to under 12 years 1½-3 tsp. (7.5-15 mL) every 6 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) (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.
Questions?

877-434-2036

Other Information (Other information)
  • each teaspoon contains: sodium 3 mg
  • store at 20°-25°C (68°-77°F)
Inactive Ingredients (Inactive ingredients)

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

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.
Principal Display Panel 118 Ml Carton (PRINCIPAL DISPLAY PANEL - 118 mL Carton)

CHILDREN'S

ACCUDIAL

ROTATING DOSING LABEL

ACCURATE DOSING

BY WEIGHT

Nasal Decongestant

Antihistamine

Cough Suppressant

RELIEVES

Nasal Congestion

Runny Nose

Itchy, Watery Eyes

Coughing, Sneezing

For Ages 6 to under 12

Alcohol Free

Compares to the

active ingredients in

Children's Dimetapp®

Cold & Cough.

GRAPE

FLAVOR

4 FL. OZ.

(118 mL)

NDC 45014-153-04

Runny Nose & Cough

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • 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

Advanced Ingredient Data


Raw Label Data

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