BROHIST D- brompheniramine maleate and phenylephrine hydrochloride tablet, coated 
Allegis Pharmaceuticals, LLC

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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Brohist D
Tablet

Drug Facts

Active IngredientsPurpose
Each tablet contains:
Brompheniramine Maleate 4 mgAntihistamine
Phenylephrine HCl 10 mgNasal Decongestant

Uses

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

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • 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 product

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes mellitus
  • difficulty in urination due to enlargement of the prostate gland

Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

When using this product

  • excitability may occur, especially in children
  • may cause drowsiness
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • If symptoms do not improve within 7 days or are accompanied by fever
  • new symptoms occur

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

Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

Do not exceed recommended dosage

Adults and children 12 years of age and over:1 tablet every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age:½ tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor
Children under 6 years of ageConsult a doctor

Other information

Store at 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Inactive ingredients

Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

Questions or Comments?

Call 866-633-9033

Manufactured for:
Allegis Pharmaceuticals, LLC
Canton, MS 39046

PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label

NDC 28595-300-60
Brohist D
Antihistamine • Nasal Decongestant

Each tablet contains:
Brompheniramine Maleate    4 mg
Phenylephrine HCl              10 mg

Tamper evident by foil seal under cap. Do not use if foil seal
is broken or missing.

ALLEGIS PHARMACEUTICALS

Manufactured for:
Allegis Pharmaceuticals, LLC
Canton, MS 39046

60 Tablets

PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label
BROHIST D 
brompheniramine maleate and phenylephrine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:28595-300
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Brompheniramine Maleate (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) Brompheniramine Maleate4 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) Phenylephrine Hydrochloride10 mg
Inactive Ingredients
Ingredient NameStrength
Magnesium Stearate (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize15mm
FlavorImprint Code 300
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:28595-300-6060 in 1 BOTTLE; Type 0: Not a Combination Product09/10/201212/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/10/201212/31/2019
Labeler - Allegis Pharmaceuticals, LLC (792272861)
Establishment
NameAddressID/FEIBusiness Operations
TG United, Inc.172837085MANUFACTURE(28595-300)

Revised: 1/2020
Document Id: a059f624-9fb8-4ca8-9723-d17f3b619c8c
Set id: 9aeaffc0-be85-4ca7-ae67-d439ccfe6511
Version: 2
Effective Time: 20200123
 
Allegis Pharmaceuticals, LLC