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

ATUSS DA by

Drug Labeling and Warnings

ATUSS DA by is a Otc medication manufactured, distributed, or labeled by Magna Pharmceuticals, Inc., Woodfield Pharmaceutical, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredients

(in each 5mL teaspoonful)

Brompheniramine Maleate 2 mg

Chlophedianol Hydrochloride 12.5 mg

Pseudoephedrine Hydrochloride 30 mg

PURPOSE

Purpose

Antihistamine

Cough Suppressant

Nasal Decongestant

INDICATIONS & USAGE

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

Warnings

Do not exceed recommended dosage.

DO NOT USE

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 DOCTOR

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 DOCTOR/PHARMACIST

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

WHEN USING

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

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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

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

Other information

Store at 59° - 86°F (15° - 30°C)

INACTIVE INGREDIENT

Inactive ingredients

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

QUESTIONS

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

INGREDIENTS AND APPEARANCE

ATUSS DA 
brompheniramine maleate, chlophedianol hydrochloride, pseudoephedrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58407-252
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN)	BROMPHENIRAMINE MALEATE	2 mg  in 5 mL
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58407-252-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/20/2018
2	NDC: 58407-252-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/20/2018
3	NDC: 58407-252-01	6 in 1 CARTON	11/20/2018
3		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/20/2018

Labeler - Magna Pharmceuticals, Inc. (620988360)

Establishment
Name	Address	ID/FEI	Business Operations
Woodfield Pharmaceutical, LLC		079398730	manufacture(58407-252)