DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE liquid

DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE by

Drug Labeling and Warnings

DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by Westminster Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 15 mL (TBSP))	Purpose
Dextromethorphan HBr 18 mg	Cough Suppressant
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 10 mg	Nasal Decongestant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
• temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help you get to sleep
  • nasal congestion due to a cold

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

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• a cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
• a cough that occurs with too much phlegm (mucus)
• difficulty in urination due to enlargement of the prostate gland

When using this product do not use more than directed

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occurs
• symptoms do not improve within 7 days or are accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
• new symptoms occur

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not take more than 6 doses in any 24-hour period
• dose as follows or as directed by a doctor

• Adults and children 12 years of age and over: 1 tablespoon every 4 hours, not to exceed 6 tablespoons in a 24 hour period.
• Children 6 to under 12 years of age: 1/2 tablespoon every 4 hours, not to exceed 3 tablespoons in a 24 hour period.
• Children under 6 years of age: Consult a doctor.

Other information

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

Inactive ingredients

Citric acid, methylparaben, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, raspberry flavor, sorbitol, sucralose

Questions or Comments?

• Call 1-844-221-7294

PRINCIPAL DISPLAY PANEL - 240 mL Bottle Label

NDC: 69367-184-08

Cough
Cold/Congestion

Dextromethorphan HBr
Guaifenesin
Phenylephrine HCl

Each 15 mL (TBSP) contains:
Dextromethorphan HBr 18 mg
Guaifenesin 200 mg
Phenylephrine HCl 10 mg

Cough Suppressant Expectorant Nasal Decongestant

Raspberry Flavor

Alcohol Free / Sugar Free
Gluten Free / Dye Free

8 fl. oz. (240 mL)

Westminster
Pharmaceuticals

INGREDIENTS AND APPEARANCE

DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE 
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69367-184
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	18 mg  in 15 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
RASPBERRY (UNII: 4N14V5R27W)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	RASPBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69367-184-08	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/15/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/15/2018

Labeler - Westminster Pharmaceuticals, LLC (079516651)