Dimetapp ®

Dimetapp ®
SPL v5
SPL
SPL Set ID 47317865-4310-4f07-8815-f3130963307d
Route
ORAL
Published
Effective Date 2023-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Brompheniramine (1 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Anhydrous Citric Acid 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 Completed Since 2021-09-15 Until 2026-07-31

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • temporarily relieves:
    • nasal congestion
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever
  • 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, 2 mg Antihistamine
Phenylephrine HCl, 5 mg Nasal decongestant
Directions
  • 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
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.
Other Information
  • each 10 mL contains: sodium 6 mg
  • store at 20-25°C (68-77°F)
Inactive Ingredients

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

Questions Or Comments?

Call 1-888-594-0828weekdays 9 AM to 5 PM EST

When Using This Product
  • do not use more than directed
  • drowsiness may occur
  • 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
  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not get better within 7 days or are accompanied by fever
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 breathing problem such as emphysema, asthma, or chronic bronchitis
Principal Display Panel 118 Ml Bottle Carton

CHILDREN'S

Dimetapp ®

BROMPHENIRAMINE MALEATE (Antihistamine)

PHENYLEPHRINE HCl (Nasal Decongestant)

PHARMACIST

RECOMMENDED

Cold &

Allergy

Relieves + comforts:

  • Stuffy, runny nose
  • Itchy, watery eyes
  • Sneezing

6+

YRS

4 FL OZ

(118 mL)

Grape Flavor • Alcohol Free

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:
    • nasal congestion
    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes due to hay fever
  • 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, 2 mg Antihistamine
Phenylephrine HCl, 5 mg Nasal decongestant
Directions
  • 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
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.
Other Information (Other information)
  • each 10 mL contains: sodium 6 mg
  • store at 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call 1-888-594-0828weekdays 9 AM to 5 PM EST

When Using This Product (When using this product)
  • do not use more than directed
  • drowsiness may occur
  • 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)
  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not get better within 7 days or are accompanied by fever
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 breathing problem such as emphysema, asthma, or chronic bronchitis
Principal Display Panel 118 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton)

CHILDREN'S

Dimetapp ®

BROMPHENIRAMINE MALEATE (Antihistamine)

PHENYLEPHRINE HCl (Nasal Decongestant)

PHARMACIST

RECOMMENDED

Cold &

Allergy

Relieves + comforts:

  • Stuffy, runny nose
  • Itchy, watery eyes
  • Sneezing

6+

YRS

4 FL OZ

(118 mL)

Grape Flavor • Alcohol Free

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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