Guaifenesin DM 100/5 mg/ 5 mL Vial/Ampoule (CD) Correct Dose - children's

Cough and Chest Congestion DM by

Drug Labeling and Warnings

Cough and Chest Congestion DM by is a Otc medication manufactured, distributed, or labeled by Plastikon Healthcare, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COUGH AND CHEST CONGESTION DM- guaifenesin dextromethorphan hydrobromide oral solution solution 
Plastikon Healthcare, 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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Guaifenesin DM 100/5 mg/ 5 mL Vial/Ampoule (CD)
Correct Dose - children's

Guaifenesin Dextromethorphan hydrobromide 100/5 mg/5 mL 12 Ampoules

Cough and Chest Congestion 12-count Pouch

Single Use Measurements, for easy accurate dosing

*COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN'S ROBITUSSIN® COUGH & CHEST CONGESTION DM

CORRECT DOSE®

Precise - Portable - Single-Use

non-drowsy Children's

COUGH & CHEST

CONGESTION DM

Detromethorphan HBr 5mg

Guaifenesin 100mg

for ages 4 and over

Cherry 12 PRE-FILLED SINGLE-USE DOSES

RELIEVES:

CHEST CONGESTION

& STUFFY NOSE

BREAKS UP MUCUS

CONTROLS COUGH

2.04 FL. OZ (60 mL)

12 - 5 mL INDIVIDUAL DOSES

Guaifenesin Dextromethorphan hydrobromide 100/5 mg/5 mL unit vial/ampoule

Directions

  • do not take more than 6 doses in any 24-hour period
  • mL = milliliter

Age (year)

Dose (mL)

(Children under 4 do not use)

4 to under 6 years

1 single-use vial (5 mL each) every 4 hours

6 to under 12 years2 single-use vial (5 mL each) every 4 hours

Adults and children 12 years & older

4 single-use vial (5 mL each) every 4 hours

Guaifenesin Dextromethorphan hydrobromide 100/5 mg/5 mL

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Guaifenesin Dextromethorphan hydrobromide 100/5 mg/5 mL

Warnings

Do not use if your child is 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

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

___________________________________________________________________

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. This could be signs of a serious condition.

_________________________________________________________________

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

Guaifenesin Dextromethorphan hydrobromide 100/5 mg/ 5 mL

Inactive ingredients cherry flavor, citric acid, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Guaifenesin Dextromethorphan hydrobromide 100/5 mg/ 5 mL

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Guaifenesin Dextromethorphan hydrobromide 100/5 mg/5 mL

Active ingredients (in each 5 mL unit)

Dextromethorphan HBr, USP 5 mg

Guaifenesin, USP 100 mg

Guaifenesin Dextromethorphan hydrobromide 100/5 mg/5 mL

Purpose

Cough Suppressant

Expectorant

Guaifenesin Dextromethorphan hydrobromide 100/5 mg/ 5 mL

Other information

  • each 5 mL contains: sodium 3 mg
  • store at 20-25°C (68-77°F). Do not Refrigerate.
  • sugar free, dye free, alcohol free
  • see end of unit/foil pouch for lot number and expiration date

Individual Pouch Principal Display Panel

Cough and Chest Congestion - Individual Pouch

CorrectDose®

Precise - Portable - Single-Use

Non-Drowsy

Children's

Cough & Chest

Congestion DM

Dextromethorphan HBr 5mg

Guaifenesin 100mg

for ages 4 and over

Cherry

1

Pre-Filled

Single-Use

Dose

LASTS UP TO

4 HOURS

WARNING:

CHOKING HAZARD

- SMALL PARTS.

KEEP OUT OF REACH

OF SMALL CHILDREN.

0.17 FL. OZ (5 mL)

COUGH AND CHEST CONGESTION DM 
guaifenesin dextromethorphan hydrobromide oral solution solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 62320-321
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
GLYCERIN (UNII: PDC6A3C0OX)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62320-321-0512 in 1 POUCH02/01/202104/29/2022
11 in 1 POUCH
15 mL in 1 AMPULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/01/202104/29/2022
Labeler - Plastikon Healthcare, LLC (041717941)
Registrant - Plastikon Healthcare, LLC (041717941)
Establishment
NameAddressID/FEIBusiness Operations
Plastikon Healthcare, LLC041717941manufacture(62320-321)

Revised: 9/2022