Drug Facts

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
use enclosed dosage cup or tablespoon (TBSP)
dose as follows or as directed by a doctor

Adults and children 12 years of age and over:	15 mL (1 TBSP) every 4 hours, not to exceed 90 mL (6 TBSP) in a 24 hour period
Children 6 to under 12 years of age:	7.5 mL (1/2 TBSP) every 4 hours, not to exceed 45 mL (3 TBSP) in a 24 hour period.
Children under 6 years of age:	Consult a doctor.

Other information

Each 15 mL (TBSP) contains Sodium 8 mg.
store at 68°-86°F (20°-30°C)

Inactive ingredients

citric acid anhydrous, glycerin, propylene glycol, purified water, raspberry flavor, sodium benzoate, sodium citrate dihydrate, sodium saccharin, sorbitol.

Questions or Comments?

Call weekdays from 9 AM to 5 PM EST at 1-844-7294. You may also report serious side effects to this phone number.

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

PRINCIPAL DISPLAY PANEL - 240 mL Bottle Label

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Product Characteristics
Color		Score
Shape		Size
Flavor	RASPBERRY	Imprint Code
Contains

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH DRUG	M012	03/15/2018

Labeler - Westminster Pharmaceuticals, LLC (079516651)