DOMETUSS-G- guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet

DOMETUSS-G by

Drug Labeling and Warnings

DOMETUSS-G by is a Otc medication manufactured, distributed, or labeled by DOMEL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each tablet)		Purpose
Guaifenesin	200 mg	Expectorant
Dextromethorphan HBr	20 mg	Cough Suppressant
Phenylephrine HCl	10 mg	Nasal Decongestant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
• temporarily reduces cough due to minor throat and bronchial irritation associated with a cold
• calm the cough control center, and relieves coughing.
• Temporarily relief nasal congestion due to the common cold
• hay fever or other upper respiratory allergies
• sinus congestion and pressure

Warnings

• Do not exceed recommended dosage

If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor.

Do not use

• if you are now taken a prescription Monoaminoxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or Parkinson's disease), or for two weeks after stopping the MAOI drug; If you do not know if you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product

Do not take this product: for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.

Do not give this product if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

Ask a doctor before use if you have

• liver disease
• if you are taking the blood thinning drug warfarin.

Stop using this product and ask a doctor if

• new symptoms occur
• symptoms do not improve within 7 days or are accompanied by fever.
• pain or fever persists or gets worse. These could be signs of a serious condition

Keep out of reach of children.

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

Directions

Do not take more than 6 doses in any 24 hours period.

Age	Dose
adults and children 12 years of age and over	1 tablets every 4 hours.
children 6 to 12 years of age	1/2 tablet every 4 hours.
children under 6 years of age	Consult a doctor.

Other information

• store at room temperature 15°- 30°C (59° - 86°F).

Tamper evident

Do not use if there is evidence of tampering.

Inactive ingredients

Dicalcium phosphate, magnesium stearate, maltodextrin, mirocrystalline cellulose, povidone, silicon dioxide, stearic acid, talc.

Questions or comments?

Calle de Diego #488
San Juan P.R. 00924

Phone: 787-767-3246
For more information visit
www.domelpharma.com

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

NDC: 53809-250-01

DOMETUSS-G

DEXTROMETHORPHAN HBr/
PHENYLEPHRINE HCl / GUAIFENESIN

• Cough Suppressant
• Nasal Decongestant
• Expectorant

100 TABLETS

INGREDIENTS AND APPEARANCE

DOMETUSS-G 
guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53809-250
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	D2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53809-250-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/11/2019
2	NDC: 53809-250-04	4 in 1 BOTTLE; Type 0: Not a Combination Product	11/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M012	11/11/2019

Labeler - DOMEL (808198837)