Dimaphen solution

Active ingredients (in each 10 ml)

Brompheniramine maleate, USP 2 mg

Phenylephrine HCl, USP 5 mg

Purposes

Antihistamine

Nasal decongestant

Uses

  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • 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 Parkinsons 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 out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosage cup provided
  • keep dosage cup with product
  • mL = milliliter

age

dose

adults and children 12 years and over

20 mL every 4 hours

children 6 to under 12 years

10 mL every 4 hours

children under 6 years

do not use

Other information

  • each 10 mL contains: sodium 4 mg
  • store at 20-25C (68-77F)

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution

Questions or comments?

1-800-616-2471

Ingredients and appearance - Product information

Dimaphen solution- Phenylephrine hcl, brompheniramine maleate

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 68788-7023
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Phenylephrine hydrochloride ( UNII: 04JA59TNSJ)( Phenylephrine - UNII: 1WS297W6MV ) 5 mgin 10 mL
Brompheniramine maleate ( UNII: IXA7C9ZN03)( Brompheniramine - UNII: H57G17P2FN ) 2 mgin 10 mL

Inactive Ingredients

Ingredient Name Code
Anhydrous citric acid ( UNII: XF417D3PSL)
Edetate disodium ( UNII: 7FLD91C86K)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Glycerin ( UNII: PDC6A3C0OX)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Saccharin sodium ( UNII: SB8ZUX40TY)
Sodium benzoate ( UNII: OJ245FE5EU)
Sorbitol ( UNII: 506T60A25R)

Product Characteristics

Color PURPLE (clear bluish-red) Flavor GRAPE

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA

Labeler - Preferred Pharmaceuticals Inc.( 791119022)

Establishment

Name ID/FEI Business Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK( 68788-7023)

Principal display panel

Childrens

Dimaphen™

ANTIHISTAMINE, Brompheniramine Maleate

NASAL DECONGESTANT, Phenylephrine HCl

Relieves Nasal Symptoms Stuffy Nose Runny Nose Sneezing

Plus Other Symptoms

Itchy, Watery Eyes

GRAPE FLAVOR

Alcohol-Free

6 yrs. and older

COMPARE TO the active ingredients of DIMETAPP® COLD & ALLERGY

4 FL. OZ. (118 mL.)

Relabeled By: Preferred Pharmaceuticals Inc.