Other
Drug Facts
Distributed by:
Glendale Inc
Villa, Park, IL 60181
Glentuss
FDA Label NDC 70147-233
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Glendale Inc for the product Glentuss (NDC 70147-233). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, do not use this product, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each teaspoonful) | Purpose |
|---|---|
| Dextromethorphan Hydrobromide 15 mg | Antitussive (cough suppressant) |
| Pseudoephedrine Hydrochloride 30 mg | Nasal Decongestant |
| Doxylamine Succinate 6.25 mg | Antihistamine |
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)
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