1. Home
  2. Labeler Index
  3. Glendale Inc
  4. 70147-233
  5. Label Information: Glentuss

FDA Label for Glentuss

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE THIS PRODUCT
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS? COMMENTS?
    16. PRINCIPAL DISPLAY PANEL - 473 ML BOTTLE LABEL

Glentuss 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
Dextromethorphan Hydrobromide 15 mgAntitussive (cough suppressant)
Pseudoephedrine Hydrochloride 30 mgNasal Decongestant
Doxylamine Succinate 6.25 mgAntihistamine

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.


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
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occur 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



  • 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.

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 6 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



Apple candy flavor, citric acid, glycerin, 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.


Principal Display Panel - 473 Ml Bottle Label



NDC 70147-0233-16

Glentuss

Antitussive
Nasal Decongestant
Antihistamine

Each teaspoonful for oral
administration contains:
Dextromethorphan HBr 15 mg
Pseudoephedrine HCl 30 mg
Doxylamine Succinate 6.25 mg

SUGAR FREE / DYE FREE
ALCOHOL FREE

Apple Candy 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 - glentuss 01

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label - glentuss 01


* Please review the disclaimer below.