FDA Label for Glenmax Peb Dm

View Indications, Usage & Precautions

Glenmax Peb Dm Product Label

The following document was submitted to the FDA by the labeler of this product Glendale Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

Distributed by:
Glendale Inc
Villa Park, IL 60181


Otc - Purpose



Active ingredients (in each teaspoonful)Purpose
Brompheniramine Maleate 2 mgAntihistamine
Dextromethorphan Hydrobromide 10 mgAntitussive (cough suppressant)
Phenylephrine Hydrochloride 5 mgNasal 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
  • itching of the nose or throat
  • itchy, watery eyes
  • nasal congestion
  • temporarily restores freer breathing through the nose congestion
  • reduces swelling of nasal passages

Warnings



Do not exceed recommended dosage.


Otc - Do Not Use



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.

Otc - Ask Doctor



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 occur with too much phlegm (mucus)

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are

  • taking any other nasal decongestant or stimulant
  • taking sedatives or tranquilizers

Otc - When Using



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

Otc - Stop Use



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.

Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



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 4 dosage in a 24-hour period.

Adults and children 12 years of age and over:2 teaspoonfuls 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



Citric acid, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol, strawberry flavor.


Questions? Comments?



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


Principal Display Panel - 473 Ml Bottle Label



NDC 70147-0230-16

Glenmax
PEB DM
Antihistamine/Antitussive
Nasal Decongestant

Each teaspoonful for oral
administration contains:

Brompheniramine Maleate 2 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

SUGAR FREE / DYE FREE
ALCOHOL FREE

Strawberry 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)


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