Drug Labeling and Warnings

Drug Details

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AKIN DM- dextromethorphan guaifenesin liquid 
Southern Sales & Service, 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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ACTIVE INGREDIENT

Active ingredient (in each 5mI tsp.) Purpose
Dextromethorphan HBr USP 10 mg.................Cough suppressant
Guaifenesin USP 10omg............................................Expectorant

INACTIVE INGREDIENT

Propylene glycol, glycerine, citric acid, sucralose, sodium citrate, potassium sorbate, methylparaben, propylparaben, cherry flavor, menthol, FD&C Red#40, purified Water.

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

See DOSAGE & ADMINISTRATION

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 you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if ° you have a cough that lasts or a chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema - cough occurs with too much phlegm (mucus)

Ask a doctor before use if

You have a cough that lasts or a
chronic cough such as occurs with smoking, asthma, chronic
bronchitis or emphysema - cough occurs with too much
phlegm (mucus)

Stop use and ask a doctor if

Cough lasts for more than 7
days, comes back, or occurs with fever, rash, or headache that
lasts. 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
overdose, get medical help or contact a Poison Control Center
right away.

DOSAGE & ADMINISTRATION

do not take more than 6 doses in any 24 hour period 
 adults and children qw years and over2 tsp every 4 hours or as
directed by doctor
 Children under 12 yearsdo not use

PURPOSE

Cough Suppressant, Expectorant

Other Information


Store at room temperature - 15°- 30°C (59°- 86°F)
TAMPER-EVIDEN : Do not use if seal under cap is
torn, broken or missing.

Akin Cough Formula DM

Label Image
AKIN DM 
dextromethorphan guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69822-201
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CHERRY (UNII: BUC5I9595W)  
MENTHOL (UNII: L7T10EIP3A)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69822-201-041 in 1 BOX01/01/2015
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/04/2014
Labeler - Southern Sales & Service, Inc. (013114906)
Establishment
NameAddressID/FEIBusiness Operations
Southern Sales & Service, Inc.013114906LABEL(69822-201)
Establishment
NameAddressID/FEIBusiness Operations
GADAL Laboratories, Inc841305639MANUFACTURE(69822-201)

Revised: 1/2017
 
Southern Sales & Service, Inc.


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