CHILDRENS COLD AND ALLERGY- brompheniramine maleate, phenylephrine hcl elixir 
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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, 1 teaspoon)

Brompheniramine maleate, USP 1 mg

Phenylephrine HCl, USP 2.5 mg

Purpose

Antihistamine

Nasal decongestant

Uses

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

 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

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 BOX
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 FINALpart34107/11/2011
Labeler - Select Brand Dist. (012578514)

Revised: 10/2014
Document Id: 79df2e83-6fc6-4d0b-98d0-cc326bbd59ad
Set id: 8fb7b5ad-4ba8-422a-9fc9-571de2c05873
Version: 1
Effective Time: 20141013
 
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