Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation nasal congestion reduces swelling of nasal passages
Do not exceed recommended dosage Adults and children 12 years of age and over 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 Children 6 to under 12 years of age 1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 3 teaspoonfuls in 24 hours Children under 6 years of age Consult a doctor.
Dexbrompheniramine Maleate 2 mg
Dextromethorphan Hydrobromide 15 mg
Phenylephrine Hydrochloride 7.5 mg
Antihistamine
Antitussive
Nasal Decongestant
Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:
runny nose
sneezing
itching of nose or throat
itchy, watery eyes
cough due to minor throat and bronchial irritation
nasal congestion
reduces swelling of nasal passages
Do not exceed recommended dosage.
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.
a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due toan enlarged prostate gland
a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
a cough that occurs with too much phlegm (mucus)
heart disease
high blood pressure
thyroid disease
you are taking sedatives or tranquilizers.
excitability may occur, especially in children
may cause marked drowsiness
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase the drowsiness effect
be careful when driving a motor vehicle or operating machinery
nervousness, dizziness, or sleeplessness occur
cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
new symptoms occur
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
Do not exceed recommended dosage
| Adults and children 12 years of age and over | 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 |
| Children 6 to under 12 years of age | 1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 3 teaspoonfuls in 24 hours |
| Children under 6 years of age | Consult a doctor. |
Store at 59° - 86°F (15° - 30°C)
Anhydrous Citric Acid, Glycerin, Flavor, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate Dihydrate, Sodium Saccharin, Sorbitol Solution.
Serious side effects associated with use of this product may be reported to this number. Call 1-800-882-1041 Mon. - Fri. (8 a.m. to 5 p.m. CST).
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50991-121-16 | ML - Milliliter | 50991-121 | d9f65432-0f6e-4248-a11e-e5e6c01e85d7 | 1 | 2021-12-08 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50991-121 | 50991-121-16, 50991-121-15 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| TRISODIUM CITRATE DIHYDRATE | B22547B95K | IACT |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| DEXBROMPHENIRAMINE MALEATE | BPA9UT29BS | ACTIB |
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 |
|---|---|---|---|---|---|---|
| 0412a938-bff6-139d-e063-6294a90ac9a2 | cf4c931c-d9e0-8599-e053-2995a90a2623 | 2023-08-29 | Warnings | cf4c931c-d9e0-8599-e053-2995a90a2623 |
Adverse event summaries are temporarily unavailable. Other product information remains available.