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#

ProductDuratuss AC
Active ingredientCODEINE PHOSPHATE, DEXBROMPHENIRAMINE MALEATE
Label structure15 sections

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

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2727418codeine phosphate 10 MG / dexbrompheniramine maleate 1 MG in 5 mL Oral SolutionPSN1
2727418codeine phosphate 2 MG/ML / dexbrompheniramine maleate 0.2 MG/ML Oral SolutionSCD1
2727418codeine phosphate 10 MG / dexbrompheniramine maleate 1 MG per 5 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CODEINE ANHYDROUS Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130350991540161GTIN-13: 0350991540161
EAN-13: 0350991540161
GTIN-12: 350991540161
UPC-A: 350991540161
GTIN storage (14 digits): 00350991540161
duratussAC_poly.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
e9576821-a971-5261-628e-82ad9e10acdbProduct name220150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50991-540-16Duratuss AC473 mL in 1 BOTTLELIQUID4731
50991-540-20Duratuss AC20 mL in 1 BOTTLELIQUID201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50991-540-16ML - Milliliter50991-540f5182ba5-8c4b-4816-8762-dcdb0fc8055812026-01-08

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50991-54050991-540-16, 50991-540-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Duratuss ACCODEINE PHOSPHATE, DEXBROMPHENIRAMINE MALEATEPoly Pharmaceuticals, Inc.3e5ed178-d5d9-b8d4-e063-6394a90a91db2025-09-09WarningsExact identifier
ndc (package): 50991-540-16
ndc (package): 50991-540-20
ndc (product): 50991-540
ndc11 (package): 50991054016
ndc11 (package): 50991054020
spl id: 3e5ed178-d5d8-b8d4-e063-6394a90a91db
spl set id: 3e5ed178-d5d9-b8d4-e063-6394a90a91db

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.