DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid 
Monarch PCM, LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Dextromethorphan HBr, Guaifenesin,and Phenylephrine HCl

Dextromethorphan HBr

Guaifenesin
Phenylephrine HCl

70154-112-08

8 fl. Oz. (240 mL)

Active ingredients (in each 15 mL (TBSP))

Dextromethorphan HBr 18 mg

Guaifenesin 200 mg

Phenylephrine HCl 10 mg

Purpose

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

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) iper 24 hours
Children 6 to under 12 years of age:7.5 mL (1/2 TBSP) every 4 hours, not to exceed 45 mL (3 TBSP) per 24 hours
Children under 6 years of age:Consult a doctor.

Other information

Inactive ingredients

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

Questions or Comments?

Call 1-844-696-6627

PRINCIPAL DISPLAY PANEL

NDC 70154-112-08

Dextromethorphan HBr
Guaifenesin
Phenylephrine HCl

Cough Suppressant • Expectorant • Nasal Decongestan

8 fl. oz. (240 mL)

PDP1

PDP2

DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE 
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70154-112
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE18 mg  in 15 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
Color    Score    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70154-112-08240 mL in 1 BOTTLE; Type 0: Not a Combination Product08/19/201908/26/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/19/201908/26/2019
Labeler - Monarch PCM, LLC. (080000294)

Revised: 4/2020
Document Id: a473b626-a3e5-7b7c-e053-2995a90ac574
Set id: 90960006-4946-0e18-e053-2a95a90a42ac
Version: 4
Effective Time: 20200429
 
Monarch PCM, LLC.