CHILDRENS COLD AND ALLERGY- brompheniramine maleate, phenylephrine hcl elixir 
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Drug Facts

Active ingredients (in each 5 mL, 1 teaspoon)

Brompheniramine maleate, USP 1 mg

Phenylephrine HCl, USP 2.5 mg

Purpose

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

  • to sedate a child or 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.

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 any other oral nasal decongestant or stimulant
  • taking sedatives or tranquilizers

When using this product

  • do not use more than directed
  • may cause marked drowsiness
  • 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 (1-800-222-1222) immediately.

Directions

  • do not take more than 6 doses in a 24-hour period 
  • use enclosed dosage cup
  • tsp = teaspoon, mL = milliliter
 age dose
adults and children 12 years and over4 teaspoons (20 mL) every 4 hours
 children 6 to under 12 years 2 teaspoons (10 mL) every 4 hours
 children under 6 yearsdo not use

Other information

  • each teaspoon contains: sodium 3 mg
  • store at room temperature

Inactive ingredients

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

Principal Display Panel

Children's Cold & Allergy Elixir

RELIEVES:

Stuffy Nose; Itchy, Watery Eyes; Runny Nose; Sneezing 

Brompheniramine Maleate - Antihistamine

Phenylephrine HCl - Nasal Decongestant

*Compare to the Active Ingredients of DIMETAPP® Elixir

Grape Flavor

Alcohol Free 

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING.

*This product is not manufactured or distributed by Wyeth Consumer Healthcare, distributors of Dimetapp®.

DISTRIBUTED BY: SELECT BRAND® DISTRIBUTORS

Pine Bluff, AR 71603 USA

AC (870) 535-3635

MADE IN THE USA

Package Label

Brompheniramine maleate 1 mg, Phenylephrine HCl 2.5 mg

Select Brand Children's Cold & Allergy Grape Elixir

CHILDRENS COLD AND ALLERGY 
brompheniramine maleate, phenylephrine hcl elixir
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-954
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
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15127-954-041 in 1 BOX07/11/201112/31/2019
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01207/11/201112/31/2019
Labeler - Select Brand Dist. (012578514)

Revised: 5/2024
Document Id: c34800ff-ab28-40c7-b0aa-97384f5ff3e7
Set id: 8fb7b5ad-4ba8-422a-9fc9-571de2c05873
Version: 2
Effective Time: 20240521
 
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