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ATUSS DA by Carwin Pharmaceutical Associates, LLC

Dosage form: liquid
Ingredients: CHLOPHEDIANOL HYDROCHLORIDE 12.5mg in 5mL, PSEUDOEPHEDRINE HYDROCHLORIDE 30mg in 5mL, BROMPHENIRAMINE MALEATE 2mg in 5mL
Labeler: Carwin Pharmaceutical Associates, LLC
NDC Code: 15370-140

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)Purpose
Brompheniramine Maleate 2 mgAntihistamine
Chlophedianol Hydrochloride 12.5 mgCough Suppressant
Pseudoephedrine Hydrochloride 30 mgNasal 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 children 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. 1-844-700-5011 8 am - 5 pm M - F CST

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 15370-140-16

ATUSS DA

Each teaspoonful (5 mL) for oral
administration contains:

Brompheniramine Maleate  2 mg
Chlophedianol HCl  12.5 mg
Pseudoephedrine HCl  30 mg

GRAPE FLAVORED LIQUID

  • Antihistamine
  • Cough Suppressant
  • Nasal Decongestant

Sugar Free/Alcohol Free
Dye Free

carwin
PHARMACEUTICAL ASSOCIATES

16 fl oz (473 mL)

ATUSS   DA
chlophedianol hydrochloride, pseudoephedrine hydrochloride, and brompheniramine maleate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15370-140
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, UNSPECIFIED FORM 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:15370-140-16473 mL in 1 BOTTLE, PLASTIC
2NDC:15370-140-04118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/25/2016
Labeler - Carwin Pharmaceutical Associates, LLC (079217215)

Revised: 10/2016
 
Carwin Pharmaceutical Associates, LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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