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DIBROMM with PE

Dosage form: liquid
Ingredients: BROMPHENIRAMINE MALEATE 1mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 5mL
Labeler: Major Pharmaceuticals
NDC Code: 0904-5781

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active Ingredients

In Each 5 mL teaspoonful:

Brompheniramine maleate USP 1 mg
Phenylephrine HCl USP 2.5 mg

Purposes

Brompheniramine maleate....................Antihistamine
Phenylephrine HCl................................Nasal decongestant

Uses

• temporarily relieves nasal congestion due to the
common cold, hay fever or other upper
respiratory allergies, or associated with sinusitis.
• 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

Warnings

Do not use

  • 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

• heart disease • high blood pressure
• thyroid disease • diabetes • glaucoma
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or
chronic bronchitis

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

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

• you get nervous, dizzy or sleepless
• symptoms do not get better within 7 days
or are accompanied by fever

If pregnant or breast-feeding

ask a health professional before use.

Keep this and all drugs out of the reach of children.

In case of accidental overdose, seek professional
assistance or contact a Poison Control Center
immediately.

Directions

do not take more than 6 doses in a 24-hour period

age                                                                     dose
adults and children 12 years and over..........4 teaspoonfuls every 4-6 hours
children 6 years to under 12 years...............2 teaspoonfuls every 4-6 hours
children 4 to under 6 years...........................do not use unless directed by a doctor
children under 4 years..................................do not use

Questions?

Call: (800) 616-2471

Other Information

• dosage cup provided
• each teaspoon contains: sodium 2 mg
• store at 20o-25oC (68o-77oF)
• not a USP elixir

Inactive Ingredients

FD&C blue 1, anhydrous citric acid, edetate disodium,
flavor, glycerin, propylene glycol, purified water,
FD&C red 40, sodium benzoate, sodium citrate, sorbitol solution,
saccharin sodium

Principal Display Panel

Major

children's Dimaphen

Elixir

Great Grape Taste

Alcohol Free; Gluten Free

4 FL OZ (118 mL)

DIBROMM  WITH PE
brompheniramine maleate, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5781
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
EDETATE SODIUM 
SORBITOL 
SACCHARIN SODIUM ANHYDROUS 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Grape Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-5781-09237 mL in 1 BOTTLE, PLASTIC
2NDC:0904-5781-20118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/07/2009
Labeler - Major Pharmaceuticals (191427277)

Revised: 09/2012
 
Major Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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