Retail Business Services, LLC. Children’s COLD & COUGH Drug Facts

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
  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes due to hay fever (or other upper respiratory allergies)
• temporarily alleviates the intensity of coughing

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

CAREone^®

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

Safe and Effective Relief without Phenylephrine

For Ages 6 and Older

Children’s

COLD & COUGH

Antihistamine – Brompheniramine Maleate, 2 mg

Cough Suppressant – Dextromethorphan HBr, 10 mg

FOR RELIEF OF:

• Runny Nose

• Itchy, Watery Eyes

• Coughing & Sneezing

• Alcohol Free

Gluten Free

Grape Flavor

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.

• CAREONE CHILDRENS COLD 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#

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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.