CHILDRENS DIMETAPP 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

Phenylephrine HCl , 5 mg

Purposes

OTC - PURPOSE SECTION

Antihistamine

Cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

• temporarily relieves:
• Nasal congestion
  • runny nose
  • cough
  • sneezing
  • itchy, watery eyes due to hay fever
  • itching of the nose or throat
• temporarily restores freer breathing through the nose

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

• 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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• 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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

• taking any other oral nasal decongestant or stimulant
• 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

• nervousness, dizziness, or sleeplessness occurs
• symptoms do not get better within 7 days or are accompanied by fever, rash, or persistent headache. These could be signs 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 at 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 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

Other information

SPL UNCLASSIFIED SECTION

• each 10 ml contains: sodium 6 mg
• store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

NDC 55319-645-04

Children's

Cold
& Cough

Brompheniramine maleate (Antihistamine)
Dextromethorphan HBr (Cough Suppressant)
Phenylephrine HCl (Nasal Decongestant)

Relieves Nasal Symptoms

• Stuffy Nose
• Runny Nose
• Sneezing

Plus Other Symptoms

• Itchy, Watery Eyes
• Cough

For Ages 6 Years and Over

Grape Flavor

Naturally and Artificially Flavored

4 FL OZ (118 ml)

Distributed by:

*This product is not distributed by Foundation Consumer Brands, LLC, the distributor of Children’s Dimetapp® Cold & Cough*.

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

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Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

• CHILDRENS DIMETAPP COLD AND COUGH
• brompheniramine maleate, dextromethorphan HBr, phenylephrine HCl
• BROMPHENIRAMINE MALEATE
• BROMPHENIRAMINE
• DEXTROMETHORPHAN HYDROBROMIDE
• DEXTROMETHORPHAN
• PHENYLEPHRINE HYDROCHLORIDE
• PHENYLEPHRINE
• ANHYDROUS CITRIC ACID
• FD&C BLUE NO. 1
• FD&C RED NO. 40
• GLYCERIN
• PROPYLENE GLYCOL
• PROPYL GALLATE
• WATER
• SODIUM BENZOATE
• SODIUM CITRATE, UNSPECIFIED FORM
• SORBITOL
• SUCRALOSE

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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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.