COLD AND COUGH- brompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid 
Meijer Distribution Inc

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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Meijer Distribution, Inc. Cold & Cough Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Brompheniramine maleate, USP 1 mg

Dextromethorphan HBr, USP 5 mg

Phenylephrine HCl, USP 2.5 mg

Purpose

Antihistamine

Cough suppressant

Nasal decongestant

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
  • temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • sneezing
  • itching of the nose or throat
  • runny nose
  • itchy, watery eyes
  • 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 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.
  • to make a child sleepy

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • thyroid disease
  • high blood pressure
  • heart disease
  • diabetes
  • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • cough that occurs with too much phlegm (mucus)
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

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
  • 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 out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • do not take more than 6 doses in any 24-hour period
agedose
adults and children 12 years and over4 tsp every 4-6 hours
children 6 to under 12 years2 tsp every 4-6 hours
children 4 to under 6 yearsdo not use unless directed by a doctor
children under 4 yearsdo not use

Other information

  • each teaspoon contains: sodium 2 mg
  • store at 20°-25°C (68°-77°F)
  • not a USP elixir

Inactive ingredients

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

Questions or comments? 

1-800-719-9260

Principal Display Panel

Compare to Dimetapp® Cold & Cough active ingredients

Children’s

Cold & Cough

Elixir

Antihistamine - brompheniramine maleate

Cough Suppressant - dextromethorphan HBr

Nasal Decongestant - phenylephrine HCl

Relieves:
Nasal Congestion

Runny Nose

Itchy, Watery Eyes

Coughing, Sneezing

Red Grape Flavor

children's

Alcohol Free

Cold & Cough Carton Image 1

Cold & Cough Carton Image 1

Cold & Cough Carton Image 2

Cold & Cough Carton Image 2

COLD AND COUGH 
brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41250-987
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM BENZOATE 
SORBITOL 
Product Characteristics
ColorPURPLE (Clear bluish-red) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41250-987-341 in 1 CARTON
1237 mL in 1 BOTTLE
2NDC:41250-987-261 in 1 CARTON
2118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/11/2006
Labeler - Meijer Distribution Inc (006959555)

Revised: 11/2011
 
Meijer Distribution Inc