ACETAFLU COUGH AND CHEST CONGESTION- dextromethorphan hbr,guaifenesin powder 
Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals

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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ACETAFLU COUGH & CHEST CONGESTION

Active Ingredients

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Purposes

Uses

Warnings

Do not use

Ask a doctor before use if you have

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions


do not use more than directed
take every 4 hours. Do not take more than 6 packets in 24 hours.

AgeDose
adults and children 12 years of age and over  one packet
 children under 12 years of agedo not use 

Other information


Inactive Ingredients.

acesulfame potassium, anhydrous citric acid, flavor, lactose, maltodextrin, mannitol, povidone K30, silicon dioxide, sodium bicarbonate, sodium chloride, sodium citrate, sucralose, sucrose

image descriptionimage description

ACETAFLU COUGH AND CHEST CONGESTION 
dextromethorphan hbr,guaifenesin powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13411-852
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 g
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 5 g
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MANNITOL (UNII: 3OWL53L36A)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13411-852-066 in 1 BOX08/31/2020
15 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:13411-852-1212 in 1 BOX08/31/2020
25 g in 1 PACKET; Type 0: Not a Combination Product
3NDC:13411-852-2020 in 1 BOX08/31/2020
35 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/31/2020
Labeler - Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals (187498279)
Establishment
NameAddressID/FEIBusiness Operations
S.P.M CORPORATION555279715manufacture(13411-852)

Revised: 8/2020
Document Id: 2be60640-112d-4b3f-add3-8ffb74ab21a6
Set id: 5a6c9b52-255b-48d9-b92e-ded3aa9e29d4
Version: 1
Effective Time: 20200831
 
Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals