ADULT TUSSIN COUGH AND CHEST CONGESTION DM- dextromethorphan hbr, guaifenesin liquid 
Akron Pharma 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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Drug Facts

Active ingredients (in each 10 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 200 mg

Purposes

Cough suppressant

Expectorant

Uses

Warnings

Do not use

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 doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or is accompanied by 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 reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

Other information

Inactive ingredients

citric acid, cherry flavor, glycerin, high fructose corn syrup, menthol crystals, purified water, sodium benzoate, sodium citrate, sodium saccharin,
sucrose.

Questions or comments?

1-877-225-6999

4oz

8oz

16oz

ADULT TUSSIN COUGH AND CHEST CONGESTION DM 
dextromethorphan hbr, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-1004
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
Colorwhite (colorless) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71399-1004-4118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/11/2022
2NDC:71399-1004-8236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/11/2022
3NDC:71399-1004-6473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/11/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34111/11/2022
Labeler - Akron Pharma Inc. (067878881)
Registrant - SLV PHARMACEUTICALS LLC (081225162)
Establishment
NameAddressID/FEIBusiness Operations
SLV PHARMACEUTICALS LLC081225162manufacture(71399-1004)

Revised: 11/2022
Document Id: c36f1658-61e2-435f-a83d-66f7b4a3dc74
Set id: 0ea4968d-34d6-487a-af0d-ebdc677c22d9
Version: 1
Effective Time: 20221111
 
Akron Pharma Inc.