DIBROMM DM- brompheniramine maleate, phenylephrine hydrochloride, dextromethorphan hydrobromide liquid 
Major Pharmaceuticals

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.

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Drug Facts

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

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)

Children's Dimaphen DM Elixir
DIBROMM  DM
brompheniramine maleate, phenylephrine hydrochloride, dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5782
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
EDETATE SODIUM (UNII: MP1J8420LU)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Grape Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-5782-20118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/07/200909/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/07/200909/30/2018
Labeler - Major Pharmaceuticals (191427277)
Registrant - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIBusiness Operations
Major Pharmaceuticals191427277REPACK(0904-5782)

Revised: 7/2018
 
Major Pharmaceuticals