ATUSS DA- chlophedianol hydrochloride, pseudoephedrine hydrochloride, and brompheniramine maleate liquid

ATUSS by

Drug Labeling and Warnings

ATUSS by is a Otc medication manufactured, distributed, or labeled by Carwin Pharmaceutical Associates, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 5 mL teaspoonful)	Purpose
Brompheniramine Maleate 2 mg	Antihistamine
Chlophedianol Hydrochloride 12.5 mg	Cough Suppressant
Pseudoephedrine Hydrochloride 30 mg	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 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)

INGREDIENTS AND APPEARANCE

ATUSS   DA
chlophedianol hydrochloride, pseudoephedrine hydrochloride, and brompheniramine maleate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15370-140
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP)	CHLOPHEDIANOL HYDROCHLORIDE	12.5 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg  in 5 mL
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN)	BROMPHENIRAMINE MALEATE	2 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15370-140-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/25/2016
2	NDC: 15370-140-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/25/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	10/25/2016

Labeler - Carwin Pharmaceutical Associates, LLC (079217215)