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

Dextromethorphan HBr USP 5 mg

Phenylephrine HCl USP 2.5 mg

Purposes

Brompheniramine maleate....................Antihistamine
Phenylephrine HCl................................Nasal decongestant
Dextromethorphan...............................Cough Suppressant

DIBROMM Uses

• temporarily relieves cough due to minor throat
and bronchial irritation occurring with a cold, and
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
• 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

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
  • cough lasts for more than 7 days, comes back, or occurs with fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition

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 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

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, citric acid, adetate disodium,
flavor, glycerin, propylene glycol, purified water,
FD&C red 40, sodium benzoate, sodium citrate, sorbitol,
saccharin sodium

Warnings

Do not use • 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.

Principal Display Panel

Major

Children's

Dimaphen DM

cold and cough elixir

red grape taste

alcohol free

4FL OZ (118 mL)

DIBROMM

DIBROMM

BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0904-5782
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
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 5 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
propylene glycol
water
SODIUM BENZOATE
sorbitol
SACCHARIN SODIUM ANHYDROUS
FD&C BLUE NO. 1
FD&C RED NO. 40
EDETATE SODIUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0904-5782-20 118 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-11-07


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Be sure to consult your doctor before taking any medication!
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