Drug Labeling and Warnings

Drug Details

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AKIN- guaifenesin solution 
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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Expectorant
SUGAR FREE / ALCOHOL

DESCRIPTION

Each 5 mL (1 teaspoonful) contains:
Guaifenesin 100 mg

Inactive Ingredients

Propylene glycol, glycerine, citric acid, sucralose, sodium citrate, potasium sorbate, methylparaben, propylparaben, cherry flavor, menthol, FD &C Red # 40 ,caramel color,purified water.

USES

Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

WARNINGS

Ask a doctor before use if you have

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

Stop use and ask a doctor if

  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
  • you are hypersensitive to any of the ingredients.

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.

DIRECTIONS

  • do not take more than 6 doses in any 24-hour period.
adults and children 12 years and over2 to 4 teaspoonfuls every 4 hours or as directed by doctor.
children under 12 yearsdo not use

STORAGE

Store at room temperature, 15°-30°C (59°-86°F).

PRINCIPAL DISPLAY PANEL

AKIN Cough Formula

AKIN 
guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69822-200
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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)  
MENTHOL (UNII: L7T10EIP3A)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69822-200-02118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/01/2015
Labeler - Southern Sales & Service, Inc. (013114906)
Establishment
NameAddressID/FEIBusiness Operations
Southern Sales & Service, Inc.013114906LABEL(69822-200)
Establishment
NameAddressID/FEIBusiness Operations
GADAL Laboratories, Inc841305639MANUFACTURE(69822-200)

Revised: 4/2017
 
Southern Sales & Service, Inc.


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