Duratuss AC
- Manufacturer
- Poly Pharmaceuticals, Inc.
- Effective date
- 2025-09-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:17:32
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients
(in each 5 mL teaspoonful)
Codeine Phosphate 10 mg ................................................... Antitussive
Dexbrompheniramine Maleate 1 mg ................................. Antihistamine
OTC - PURPOSE SECTION
Antihistamine
Antitussive
INDICATIONS & USAGE SECTION
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
WARNINGS SECTION
Warnings
Do not exceed recommended dosage.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urination due to the enlargement of the 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
- a chronic pulmonary disease or shortness of breath, or children who are taking other drugs
- heart disease
- high blood pressure
- thyroid disease
- diabetes
OTC - WHEN USING SECTION
When using this product
- excitability may occur, especially in children
- may cause marked drowsiness
- avoid alcoholic drinks
- may cause or aggravate constipation
- alcohol, sedatives, and tranquilizers may increase drowsiness effect
OTC - STOP USE SECTION
Stop use and ask a doctor if
- 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. These could be signs of a serious condition.
- new symptoms occur
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breastfeeding ask a health professional before use
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away
OTC - DO NOT USE SECTION
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.
DOSAGE & ADMINISTRATION SECTION
Directions
Adults 12 and over: 10 mL every 4-6 hours
Not to exceed 60 mL in 24 hours or as directed by a doctor
Children 6-12: 5 mL every 4 hours,
Not to exceed 30 mL in 24 hrs or as directed by a doctor
Children under 6: Consult a doctor
OTHER SAFETY INFORMATION
Other information
Store at room temperature 15°C-30°C (59°F-86°F)
Questions? Comments? 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).
INACTIVE INGREDIENT SECTION
Inactive ingredients
Inactive ingredients Cherry flavor, citric acid, glycerin, propylene glycol, purified water,sodium benzoate, sodium citrate, sorbitol solution, sucralose.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2727418 | codeine phosphate 10 MG / dexbrompheniramine maleate 1 MG in 5 mL Oral Solution | PSN | 1 |
| 2727418 | codeine phosphate 2 MG/ML / dexbrompheniramine maleate 0.2 MG/ML Oral Solution | SCD | 1 |
| 2727418 | codeine phosphate 10 MG / dexbrompheniramine maleate 1 MG per 5 ML Oral Solution | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CODEINE ANHYDROUS Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0350991540161 | GTIN-13: 0350991540161 EAN-13: 0350991540161 GTIN-12: 350991540161 UPC-A: 350991540161 GTIN storage (14 digits): 00350991540161 | duratussAC_poly.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50991-540-16 | Duratuss AC | 473 mL in 1 BOTTLE | LIQUID | 473 | 1 | |
| 50991-540-20 | Duratuss AC | 20 mL in 1 BOTTLE | LIQUID | 20 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50991-540-16 | ML - Milliliter | 50991-540 | f5182ba5-8c4b-4816-8762-dcdb0fc80558 | 1 | 2026-01-08 |
Products#
Every source-derived product name is available through these pages.
- Duratuss AC
- Codeine Phosphate, Dexbrompheniramine Maleate
- GLYCERIN
- ANHYDROUS CITRIC ACID
- SORBITOL
- WATER
- CODEINE PHOSPHATE
- CODEINE ANHYDROUS
- METHYLPARABEN
- PROPYLENE GLYCOL
- SUCRALOSE
- SODIUM CITRATE
- SODIUM BENZOATE
- DEXBROMPHENIRAMINE MALEATE
- DEXBROMPHENIRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50991-540 | 50991-540-16, 50991-540-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| SORBITOL | 506T60A25R | IACT |
| WATER | 059QF0KO0R | IACT |
| CODEINE PHOSPHATE | GSL05Y1MN6 | ACTIB |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| DEXBROMPHENIRAMINE MALEATE | BPA9UT29BS | 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 |
|---|---|---|---|---|---|---|
| Duratuss AC | CODEINE PHOSPHATE, DEXBROMPHENIRAMINE MALEATE | Poly Pharmaceuticals, Inc. | 3e5ed178-d5d9-b8d4-e063-6394a90a91db | 2025-09-09 | Warnings | 50991-540-16 50991-540-20 50991-540 50991054016 50991054020 3e5ed178-d5d8-b8d4-e063-6394a90a91db 3e5ed178-d5d9-b8d4-e063-6394a90a91db |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
