OTC Medication Information: Childrens Cold and Allergy

CHILDRENS COLD AND ALLERGY- brompheniramine maleate and phenylephrine hydrochloride elixir
Select Brand Dist.

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.

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 over 4 teaspoons (20 mL) every 4 hours
children 6 to under 12 years 2 teaspoons (10 mL) every 4 hours
children under 6 years do 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
(click image for full-size original)

Select Brand Children’s Cold & Allergy Grape Elixir

CHILDRENS COLD AND ALLERGY
brompheniramine maleate, phenylephrine hcl elixir
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:15127-954
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE 1 mg in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
PROPYLENE GLYCOL
WATER
SODIUM BENZOATE
TRISODIUM CITRATE DIHYDRATE
SORBITOL
SUCRALOSE
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:15127-954-04 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
1 118 mL in 1 BOTTLE, PLASTIC This package is contained within the BOX (15127-954-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 07/11/2011
Labeler — Select Brand Dist. (012578514)

Revised: 10/2014 Select Brand Dist.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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