DIBROMM WITH PE - brompheniramine maleate and phenylephrine hydrochloride liquid 
Major Pharmaceuticals

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Drug Facts

Active Ingredients

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

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 exceed 6 doses in a 24-hour period

age                                                                     dose
adults and children 12 years and over........4 teaspoonfuls every 4 hours
children 6 years to under 12 years...............2 teaspoonfuls every 4 hours
children under 6 years...................................do not use

Questions?

Adverse Drug Event Call: (800) 616-2471

Other Information

• dosage cup provided
• each teaspoon contains: sodium 3 mg
• store at controlled room temperature
• not a USP elixir

Inactive Ingredients

blue 1, citric acid,
flavor, glycerin, propylene glycol, purified water,
red 40, sodium benzoate, sodium citrate, sorbitol,
sucralose

Principal Display Panel

Major

children's Dimaphen

Elixir

Great Grape Taste

Alcohol Free

8 FL OZ (237 mL)

DIBROMM  WITH PE brompheniramine maleate, phenylephrine hydrochloride   liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0904-5781 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE 1 mg  in 5 mL PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE   Glycerin   Propylene Glycol   Water   Sodium Benzoate   Sodium Citrate   Sorbitol   Sucralose   FD&C BLUE NO. 1   FD&C RED NO. 40

Product Characteristics Color      Score      Shape Size Flavor GRAPE (Grape Flavor) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0904-5781-09 237 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/07/2009

Labeler - Major Pharmaceuticals (191427277)

Registrant - Aaron Industries, Inc. (101896231)

Establishment
Name	Address	ID/FEI	Operations
Aaron Industries, Inc.		101896231	manufacture, analysis

Revised: 11/2009Major Pharmaceuticals