GLENMAX PEB- phenylephrine hydrochloride and brompheniramine maleate syrup 
Glendale 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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Glenmax PEB

Drug Facts

Active ingredients
(in each teaspoonful)
Purpose
Brompheniramine Maleate 4 mgAntihistamine
Phenylephrine Hydrochloride 10 mgNasal Decongestant

Uses

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

Warnings

Do not exceed recommended dosage.

Do not use this product

  • to sedate a child or 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 nasal decongestant or stimulant
  • taking sedatives or tranquilizers

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • 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 reach of children.

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

Directions

Do not exceed 6 dosage in a 24-hour period.

Adults and children 12 years of age and over:1 teaspoonful every 4 hours
Children under 12 years of age:Consult a physician

Other information

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

Inactive ingredients

Fruit gum flavor, citric acid, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol.

Questions? Comments?

To report a serious adverse event or obtain product information, Call 1-630-530-7000.

Distributed by:
Glendale Inc
Villa Park, IL 60181

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 70147-0222-16

Glenmax
PEB
Antihistamine
Nasal Decongestant

Each teaspoonful for oral
administration contains:

Brompheniramine Maleate
4 mg

Phenylephrine HCl
10 mg

SUGAR FREE / DYE FREE
ALCOHOL FREE

Fruit Gum Flavored Liquid

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

Distributed by:
Glendale Inc
Villa Park, IL 60181

16 fl oz. (473 mL)

Principal Display Panel - 473 mL Bottle Label
GLENMAX PEB 
phenylephrine hydrochloride and brompheniramine maleate syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70147-222
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE4 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70147-222-16473 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 FINALpart34112/05/2015
Labeler - Glendale Inc (079987961)

Revised: 12/2015
Document Id: 8a488a0b-e95e-4f4c-9e49-9282ad17ce9e
Set id: fa8015d5-a6ef-4651-955f-549618d75810
Version: 1
Effective Time: 20151209
 
Glendale Inc