ATUSS DA

Manufacturer
Magna Pharmceuticals, Inc. | Woodfield Pharmaceutical, LLC
Effective date
2021-11-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:44:39

Label at a glance#

ProductATUSS DA
Active ingredientBROMPHENIRAMINE MALEATE, CHLOPHEDIANOL HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure17 sections

Storage and handling

Other information Store at 59° - 86°F (15° - 30°C)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

(in each 5mL teaspoonful)

Brompheniramine Maleate 2 mg

Chlophedianol Hydrochloride 12.5 mg

Pseudoephedrine Hydrochloride 30 mg

OTC - PURPOSE SECTION

Purpose

Antihistamine

Cough Suppressant

Nasal Decongestant

INDICATIONS & USAGE SECTION

Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • reduces swelling of nasal passages
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

WARNINGS SECTION

Warnings

Do not exceed recommended dosage.

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 physician or pharmacist before taking this product.

OTC - ASK DOCTOR SECTION

Ask a physician before use if you have

  • 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
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a physician or pharmacist before use if you are taking sedatives or tranquilizers.

OTC - WHEN USING SECTION

When using this product

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

OTC - STOP USE SECTION

Stop use and ask a physician 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional befor use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

In case of an accidental overdose, seek professional help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

Do not exceed recommended dosage.

Adults and children 12 years of age and over:

2 teaspoonfuls (10 mL) every 6 hours, not to exceed 8 teapoonfuls (40 mL) in

24 hours.

Children 6 to under

12 years of age:

1 teaspoonful (5 mL) every 6 hours, not to exceed 4 teaspoonfuls (20 mL) in

24 hours.

Children under

6 years of age:

Consult a physician

STORAGE AND HANDLING SECTION

Other information

Store at 59° - 86°F (15° - 30°C)

INACTIVE INGREDIENT SECTION

Inactive ingredients

Citric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

OTC - QUESTIONS SECTION

Questions? Comments?

Call your physician for medical advice. Serious side effects associated with this product may be reported to this number. 1-888-206-5525, 8 am - 5 pm, M-F EST

SPL UNCLASSIFIED SECTION

Manufactured for:

MAGNA

Phamaceuticals, Inc.

Accountability.

Louisvill, KY 40299

magnaweb.com

Rev. 01/18

ATUSS DA 4fl oz (118 mL) Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Atuss DA LabelingAtuss DA Labeling

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1014331brompheniramine maleate 2 MG / chlophedianol HCl 12.5 MG / pseudoephedrine HCl 30 MG in 5 mL Oral SolutionPSN4
1014331brompheniramine maleate 0.4 MG/ML / chlophedianol hydrochloride 2.5 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral SolutionSCD4
1014331brompheniramine maleate 2 MG / chlophedianol hydrochloride 12.5 MG / pseudoephedrine hydrochloride 30 MG per 5 ML Oral SolutionSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PSEUDOEPHEDRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58407-252-012022-07-29C16284748780-1e4f33bdf-b061-d8a0-e053-dadaa90a6e4eATUSS DA
58407-252-042022-07-29C16284748780-1e4f33bdf-b061-d8a0-e053-dadaa90a6e4eATUSS DA
58407-252-162022-07-29C16284748780-1e4f33bdf-b061-d8a0-e053-dadaa90a6e4eATUSS DA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58407-252-01ATUSS DA15 mL in 1 BOTTLELIQUID154
58407-252-01ATUSS DA6 in 1 CARTONLIQUID64
58407-252-04ATUSS DA118 mL in 1 BOTTLELIQUID1184
58407-252-16ATUSS DA473 mL in 1 BOTTLELIQUID4734

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58407-252ATUSS DA (BROMPHENIRAMINE MALEATE, CHLOPHEDIANOL HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [MAGNA PHARMCEUTICALS, INC.]4Legacy NDC, 4 package rows20211103_7ba8db45-f5b6-5d32-e053-2991aa0a77b7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58407-252-04ML - Milliliter58407-2520db69bfc-d992-495c-99f5-692ab6da254412019-01-24

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58407-25258407-252-04, 58407-252-16, 58407-252-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML · Source PDF

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
cfd483f8-67e5-5ad7-e053-2995a90a8bd57ba8db45-f5b6-5d32-e053-2991aa0a77b72021-11-02WarningsExact identifier
spl id: cfd483f8-67e5-5ad7-e053-2995a90a8bd5
spl set id: 7ba8db45-f5b6-5d32-e053-2991aa0a77b7

Reported adverse events (FAERS/openFDA)#

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