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ATUSS DA by ABER Pharmaceuticals, LLC

Dosage form: liquid
Ingredients: CHLOPHEDIANOL HYDROCHLORIDE 12.5mg in 5mL, PSEUDOEPHEDRINE HYDROCHLORIDE 30mg in 5mL, BROMPHENIRAMINE MALEATE 2mg in 5mL
Labeler: ABER Pharmaceuticals, LLC
NDC Code: 67523-101

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ATUSS DA

Drug Facts

Active ingredients

(in each 5 mL teaspoonful)

Brompheniramine Maleate 2 mg

Chlophedianol Hydrochloride 12.5 mg

Pseudoephedrine Hydrochloride 30 mg

Purpose

Antihistamine

Cough Suppressant

Nasal Decongestant

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
  • itching of the nose or throat
  • itchy, watery eyes

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 physician or pharmacist before taking this product.

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

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

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

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.

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

Keep out of the reach of children.

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

Directions

Do not exceed recommended dosage.

Adults and childen

12 years of age

and over:

2 teaspoonfuls (10 mL)

every 6 hours, not to

exceed 8 teaspoonfuls

(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.

Other information

Store at 59° - 86°F (15° - 30°C)

Inactive ingredients

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

Questions? Comments?

Call your physician for medical advice. Serious side effects associated with this product may be reported to this number, 1-804-496-6601, 8 am - 5 pm, M - F CST.

Manufactured for:

ABER Pharmaceuticals, LLC

Ashland, VA 23005

Rev. 01/16

ATUSS DA 16 fl oz (473 mL) Bottle Label

ATUSS DA 
brompheniramine maleate, chlophedianol hydrochloride, pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67523-101
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOPHEDIANOL HYDROCHLORIDE (CHLOPHEDIANOL) CHLOPHEDIANOL HYDROCHLORIDE12.5 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE2 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
SACCHARIN SODIUM 
SODIUM CITRATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:67523-101-16473 mL in 1 BOTTLE
2NDC:67523-101-04118 mL in 1 BOTTLE
3NDC:67523-101-156 BOTTLE in 1 CARTON
315 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/08/2016
Labeler - ABER Pharmaceuticals, LLC (043455756)
Establishment
NameAddressID/FEIOperations
Woodfield Phamaceutical, LLC079398730api manufacture(67523-101)

 
ABER Pharmaceuticals, LLC

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Medically reviewed on Oct 29, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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