Cough and Chest Congestion DM
- Manufacturer
- Plastikon Healthcare, LLC
- Effective date
- 2021-12-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:22:18
Label at a glance#
ProductCough and Chest Congestion DM
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure1 sections
Contacts and useful links#
Label contents#
Full prescribing information#
Guaifenesin Dextromethorphan hydrobromide 100/5 mg/5 mL 12 Ampoules
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 years | 2 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
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)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 62320-321-05 | 2022-09-23 | C162847 | 48780-1 | e4f33bdf-a3eb-d8a0-e053-dadaa90a6e4e | Guaifenesin DM 100/5 mg/ 5 mL Vial/Ampoule (CD) Correct Dose - children's |
| 62320-321-05 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-a3eb-d8a0-e053-dadaa90a6e4e | Guaifenesin DM 100/5 mg/ 5 mL Vial/Ampoule (CD) Correct Dose - children's |
Products#
Every source-derived product name is available through these pages.
- Cough and Chest Congestion DM
- Guaifenesin Dextromethorphan hydrobromide Oral Solution
- SUCRALOSE
- XANTHAN GUM
- GLYCERIN
- ANHYDROUS CITRIC ACID
- PROPYLENE GLYCOL
- SACCHARIN SODIUM
- SACCHARIN
- SORBITOL
- SODIUM BENZOATE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 62320-321 | 62320-321-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SORBITOL | 506T60A25R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| e95f0c2d-9102-7494-e053-2995a90a7ac5 | c0e11ee5-f9d0-44a1-e053-2995a90a5c2f | 2022-09-23 | Warnings | c0e11ee5-f9d0-44a1-e053-2995a90a5c2f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.