Indications and 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
Tussin Cough DM
- Manufacturer
- P & L Development, LLC
- Effective date
- 2023-06-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:30:16
Label at a glance#
ProductTussin Cough DM Sugar Free
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure10 sections
Dosage and administration
do not take more than 6 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device keep dosing cup with product mL = milliliter this adults product is not intended for use in children under 12 years of age adults and children 12 years and over: 10 mL every 4 hours children under 12 years: do not use
Storage and handling
store between 20-25ºC (68-77º). Do not refrigerate.
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each 10 mL)
Dextromethorphan HBr 20 mg
Guaifenesin 200 mg
Purposes
Cough suppressant
Expectorant
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
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
- cough that occurs with too much phlegm (mucus)
- cough that 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. These could be signs of a serious condition.
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 (1-800-222-1222) right away.
Directions
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- mL = milliliter
- this adults product is not intended for use in children under 12 years of age
- adults and children 12 years and over: 10 mL every 4 hours
- children under 12 years: do not use
Other information
- store between 20-25ºC (68-77º). Do not refrigerate.
Inactive ingredients
acesulfame potassium, citric acid, flavors, glycerin, methylparaben, polyethylene glycol, povidone, propylene glycol, purified water, saccharin sodium, sodium benzoate
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredients in Robitussin® Peak Cold Sugar-Free Cough + Chest Congestion DM*
adult
TUSSIN dm
sugar-free
cough & chest Congestion
Dextromethorphan HBr
Guaifenesin
Relieves:
- Cough
- Mucus
for ages 12 years & over
alcohol-free
non-drowsy
specially formulated for diabetics
FL OZ (mL)
Dosing Cup Included
*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Robitussin® Peak Cold Sugar-Free Cough+Chest Congestion DM.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
Manufactured by:
PL Developments
11865 S. Almaneda St
Lynwood, CA 90262
Package Label
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49580-0817-4 | 2023-06-07 | C162847 | 48780-1 | f386c64a-0fe6-0266-e053-dadaa90a7c1a | Drug Facts |
| 49580-0817-4 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0fe6-0266-e053-dadaa90a7c1a | Drug Facts |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49580-0817 | TUSSIN COUGH DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [P & L DEVELOPMENT, LLC] | 4 | Legacy NDC | 20230609_35dd15f5-86df-4770-824e-65474b9db217.zip |
Products#
Every source-derived product name is available through these pages.
- Tussin Cough DM Sugar Free
- Dextromethorphan HBr, Guaifenesin
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
- ACESULFAME POTASSIUM
- ANHYDROUS CITRIC ACID
- GLYCERIN
- METHYLPARABEN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- PROPYLENE GLYCOL
- WATER
- SACCHARIN SODIUM
- SODIUM BENZOATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49580-0817 | 49580-0817-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
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 |
|---|---|---|---|---|---|---|
| b9888235-d2be-4e53-a188-8aca74e18e6e | 35dd15f5-86df-4770-824e-65474b9db217 | 2023-06-07 | Warnings | b9888235-d2be-4e53-a188-8aca74e18e6e 35dd15f5-86df-4770-824e-65474b9db217 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.