Indications and uses
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
Guaifenesin and Dextromethorphan hydrobromide
- Manufacturer
- Oncor Pharmaceuticals | Quality CDMO
- Effective date
- 2025-01-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:43:24
Label at a glance#
ProductGuaifenesin and Dextromethorphan hydrobromide
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure15 sections
Dosage and administration
do not exceed recommended dosage. adults and children 12 years and over: 2 teaspoonfuls (10 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours or as directed by a doctor children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours or as directed by a doctor children under 6 years of age: consult a physician
Storage and handling
- store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature] - tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients
(in each 5 mL teaspoonful) Purpose
Dextromethorphan
Hydrobromide 10 mg..........Cough Suppressant
Guaifenesin 200 mg.......................Expectorant
Uses
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
Warnings
Do not exceed recommended dosage.
Do not use this product
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
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
- cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use.
Directions
do not exceed recommended dosage.
| adults and children 12 years and over: | 2 teaspoonfuls (10 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours or as directed by a doctor |
| children 6 to under 12 years of age: | 1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours or as directed by a doctor |
| children under 6 years of age: | consult a physician |
Inactive ingredients
cherry flavor, citric acid, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose.
Other information
- store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature]
- tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
OVERDOSAGE SECTION
In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.
OTC - QUESTIONS SECTION
You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.
Principal Display Panel
Oncor Pharmaceuticals
NDC 83720-505-16
Guaifenesin and Dextromethorphan hydrobromide USP
200 mg/10 mg
Expectorant
Cough Suppressant
Non Drowsy - Alcohol Free
For Ages 12 & Up
CHERRY FLAVOR
NET WT. 16 fl. oz. (473 ml)
NDC 83720-505-04
Guaifenesin and Dextromethorphan hydrobromide USP
200 mg/10 mg
Expectorant
Cough Suppressant
Non Drowsy - Alcohol Free
For Ages 12 & Up
CHERRY FLAVOR
NET WT. 4 OZ. (118 ml)
Manufactured In USA For :
Oncor Pharmaceuticals
6755 Business Pkwy Suite 202
Elkridge, MD 21075
United States.
Rev. 12/24
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 83720-505-04 | ML - Milliliter | 83720-505 | 45ea284e-4c8c-4ed2-97b2-95fdeaf866f6 | 1 | 2025-02-10 |
| 83720-505-16 | ML - Milliliter | 83720-505 | 3feab8a0-a823-4bd2-aa17-e27473baa7e8 | 1 | 2025-02-10 |
Products#
Every source-derived product name is available through these pages.
- Guaifenesin and Dextromethorphan hydrobromide
- CITRIC ACID
- FD&C RED NO. 40
- GLYCERIN
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- SODIUM CITRATE
- SODIUM SACCHARIN
- SORBITOL SOLUTION
- CHERRY
- SUCRALOSE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 83720-505 | 83720-505-16, 83720-505-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CITRIC ACID | 2968PHW8QP | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SODIUM SACCHARIN | SB8ZUX40TY | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| CHERRY | BUC5I9595W | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | 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 |
|---|---|---|---|---|---|---|
| 2d93a3be-a01f-6311-e063-6294a90aaf47 | 42d32038-080d-484b-890e-d77af482b57b | 2025-02-07 | Warnings | 42d32038-080d-484b-890e-d77af482b57b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.