NDC | 70147-233-16 |
Set ID | 8a6eb670-8bed-4941-b4fd-70b3f1e48401 |
Category | HUMAN OTC DRUG LABEL |
Packager | Glendale Inc |
Generic Name | |
Product Class | alpha-Adrenergic Agonist, Antihistamine |
Product Number | |
Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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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
- Directions
- Other information
- Inactive ingredients
- Questions? Comments?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
NDC 70147-0233-16
Glentuss
Antitussive
Nasal Decongestant
AntihistamineEach teaspoonful for oral
administration contains:
Dextromethorphan HBr 15 mg
Pseudoephedrine HCl 30 mg
Doxylamine Succinate 6.25 mgSUGAR FREE / DYE FREE
ALCOHOL FREEApple 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 6018116 fl oz. (473 mL)
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INGREDIENTS AND APPEARANCE
GLENTUSS
dextromethorphan hydrobromide, pseudoephedrine hydrochloride, and doxylamine succinate syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70147-233 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg in 5 mL PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg in 5 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color Score Shape Size Flavor APPLE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70147-233-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 12/05/2015 Labeler - Glendale Inc (079987961)