DIBROMM description, usages, side effects, indications, overdosage, supplying and lots more!

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DIBROMM

Major Pharmaceuticals

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

DIBROMM 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

DIBROMM

BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0904-5781
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Brompheniramine Maleate BROMPHENIRAMINE 1 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg

Inactive Ingredients

Ingredient Name Strength
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

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0904-5781-09 237 in 1 BOTTLE, PLASTIC
2 NDC:0904-5781-20 118 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-01-07


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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