CHILDRENS COLD AND COUGH

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredients (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Brompheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Purposes

OTC - PURPOSE SECTION

Antihistamine

Cough suppressant

Uses

INDICATIONS & USAGE SECTION

• temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold
• temporarily relieves these symptoms due to hay fever (allergic rhinitis):
• runny nose
• sneezing
• itchy, watery eyes
• itching of the nose or throat

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

• 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.
• to make a child sleepy

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• trouble urinating due to an enlarged prostate gland
• glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem such as emphysema or chronic bronchitis
• cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

• do not take more than 6 doses in any 24-hour period
• measure only with dosage cup provided
• keep dosage cup with product
• mL = milliliter

age	dose
adults and children 12 years over	20 mL every 4 hours
children 6 to under 12 years	10 mL every 4 hours
children under 6 years	do not use

Other information

OTHER SAFETY INFORMATION

• each 10 mL contains: sodium 4 mg
• store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Children’s Dimetapp^® Cold & Cough active ingredients

H-E-B_®

Children’s Cold & Cough

Brompheniramine Maleate/Antihistamine

Dextromethorphan HBr/Cough Suppressant

Multi-Symptom

For Ages 6 Yrs. & Over

Relief of:

• Runny Nose

• Itchy, Watery Eyes

• Coughing

• Sneezing

Safe and Effective Relief without Phenylephrine

Grape Flavor

Alcohol Free

4 FL OZ (118 mL)

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

DailyMed Package Descriptions#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

• CHILDRENS COLD AND COUGH
• brompheniramine maleate, dextromethorphan hydrobromide
• BROMPHENIRAMINE MALEATE
• BROMPHENIRAMINE
• DEXTROMETHORPHAN HYDROBROMIDE
• DEXTROMETHORPHAN
• ANHYDROUS CITRIC ACID
• EDETATE DISODIUM
• FD&C BLUE NO. 1
• FD&C RED NO. 40
• GLYCERIN
• PROPYLENE GLYCOL
• WATER
• SACCHARIN SODIUM
• SODIUM BENZOATE
• SORBITOL SOLUTION

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.