ATUSS DA- brompheniramine maleate, chlophedianol hydrochloride, pseudoephedrine hydrochloride liquid 
Magna Pharmceuticals, Inc.

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.

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ATUSS DA

Drug Facts

Active ingredients

(in each 5mL 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:

Warnings

Do not exceed recommended dosage.

Do not use this product

Ask a physician before use if you have

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

When using this product

Stop use and ask a physician if

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

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. 1-888-206-5525, 8 am - 5 pm, M-F EST

Manufactured for:

MAGNA

Phamaceuticals, Inc.

Accountability.

Louisvill, KY 40299

magnaweb.com

Rev. 01/18

ATUSS DA 4fl oz (118 mL) Bottle Label

Atuss DA Labeling

ATUSS DA 
brompheniramine maleate, chlophedianol hydrochloride, pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58407-252
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE2 mg  in 5 mL
CHLOPHEDIANOL HYDROCHLORIDE (UNII: 69QQ58998Y) (CHLOPHEDIANOL - UNII:42C50P12AP) CHLOPHEDIANOL HYDROCHLORIDE12.5 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58407-252-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product11/20/2018
2NDC:58407-252-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product11/20/2018
3NDC:58407-252-016 in 1 CARTON11/20/2018
315 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/20/2018
Labeler - Magna Pharmceuticals, Inc. (620988360)
Establishment
NameAddressID/FEIBusiness Operations
Woodfield Pharmaceutical, LLC079398730manufacture(58407-252)

Revised: 11/2021
Document Id: cfd483f8-67e5-5ad7-e053-2995a90a8bd5
Set id: 7ba8db45-f5b6-5d32-e053-2991aa0a77b7
Version: 4
Effective Time: 20211102
 
Magna Pharmceuticals, Inc.