GUAIFENESIN, DEXTROMETHORPHAN HBR capsule, liquid filled

GUAIFENESIN, DEXTROMETHORPHAN HBR by

Drug Labeling and Warnings

GUAIFENESIN, DEXTROMETHORPHAN HBR by is a Otc medication manufactured, distributed, or labeled by OPMX LLC, MEDGEL PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Dextromethorphan HBr 20mg

Guaifenesin 400mg

PURPOSE

Cough suppressant

Expectorant

INACTIVE INGREDIENT

FD&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

DOSAGE & ADMINISTRATION

Do not take more than directed – See overdose warning

Do not use for more than 7 days
Do not take more than 6 doses in 24 hours

Adults and children 12 years of age and over: take 1 softgel every 4 hours with a full glass of water while symptoms persist

Children under 12 years of age: do not use

INDICATIONS & USAGE

Helps loosen phlegm (mucus)
Helps thin bronchial secretions to make coughs more productive

WARNINGS

Do not use:

• 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:

• Cough that occurs with too much phlegm (mucus)
• Cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if:

Cough lasts for more than 7 days, recurs, or is accompanied by 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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

OTHER SAFETY INFORMATION

store at room temperature between 20-25°C (68-77ºF)

avoid excessive heat and humidity

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GUAIFENESIN, DEXTROMETHORPHAN HBR 
guaifenesin, dextromethorphan hbr capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69729-783
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
GLYCERIN (UNII: PDC6A3C0OX)
GELATIN (UNII: 2G86QN327L)
POVIDONE K30 (UNII: U725QWY32X)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
SORBITAN (UNII: 6O92ICV9RU)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color	yellow (LIGHT YELLOW)	Score	no score
Shape	OVAL (Oblong)	Size	20mm
Flavor		Imprint Code	781
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69729-783-02	20 in 1 BLISTER PACK; Type 0: Not a Combination Product	02/18/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/18/2019

Labeler - OPMX LLC (029918743)