Trexbrom

Dosage form: liquid
Ingredients: BROMPHENIRAMINE MALEATE 4mg in 5mL, CHLOPHEDIANOL HYDROCHLORIDE 25mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 5mL
Labeler: Capellon Pharmaceuticals, LLC
NDC Code: 64543-501

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.

Trexbrom Liquid

Drug Facts

Active Ingredients

In each 5 mL (1 teaspoonful) bubblegum flavored liquid

Brompheniramine Maleate, USP   4 mg

Chlophedianol HCL, USP   25 mg

Phenylephrine HCl, USP   10 mg

Purpose

Brompheniramine Maleate         Antihistamine

Chlophedianol HCl                         Antitussive

Phenylephrine HCl                         Nasal decongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

cough due to minor throat and bronchial irritation
runny nose
sneezing
itchy, watery eyes
itching of the nose or throat
nasal congestion
reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do not use this product
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 drug.

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
a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
a cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are
taking any other nasal decongestant or stimulant
taking sedatives or tranquilizers

When using this product
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
nervousness, dizziness, or sleeplessness occur
cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding
ask a health professional before use.

Keep out of the reach of children

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Directions

Do not exceed 6 doses in a 24-hour period

AgeDose
Adults and children over 12 years of age1 teaspoonful (5 mL) every 6 hours
Children 6 to under 12 years of age1/2 teaspoonful (2.5 mL) every 6 hours
Children under 6 years of ageConsult a physician

Other Information

store at 20°-25°C (68°-77°F)

Inactive Ingredients

benzoic acid, bubblegum flavor, citric acid, edetate disodium USP, glycerin, propylene glycol,  purified water, saccharin sodium, sodium citrate dihydrate, and sorbitol

Questions or Comments

Serious side effects may be reported to this number, call (817) 595-5820. (8 am to 5 CST)

Principal Display Panel

Figure 1: 16 fl. oz. Bottle Label

Figure 2: 4 fl. oz. Bottle Label

Figure 3: 20 mL Bottle Label

TREXBROM 
brompheniramine maleate / chlophedianol hydrochloride / phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64543-501
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE4 mg  in 5 mL
CHLOPHEDIANOL HYDROCHLORIDE (CHLOPHEDIANOL) CHLOPHEDIANOL HYDROCHLORIDE25 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
ANHYDROUS CITRIC ACID 
EDETATE DISODIUM 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM DIHYDRATE 
SODIUM CITRATE 
SORBITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:64543-501-16473 mL in 1 BOTTLE
2NDC:64543-501-04118 mL in 1 BOTTLE
3NDC:64543-501-0120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/31/201106/30/2013
Labeler - Capellon Pharmaceuticals, LLC (124568093)
Establishment
NameAddressID/FEIOperations
Sovereign Pharmaceuticals, LLC623168267MANUFACTURE

Revised: 06/2012
 
Capellon Pharmaceuticals, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web2)