FSA Store Inc. Adult Tussin Drug Facts

caring mill adult tussin by

Drug Labeling and Warnings

caring mill adult tussin by is a Otc medication manufactured, distributed, or labeled by FSA Store Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CARING MILL ADULT TUSSIN- dextromethorphan hbr, guaifenesin solution 
FSA Store Inc.

----------

FSA Store Inc. Adult Tussin Drug Facts

Active ingredients (in each 10 mL)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

Purposes

Cough suppressant

Expectorant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

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 for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • this adult product is not intended for use in children under 12 years of age

age

dose

adults and children 12 years and over

10 mL every 4 hours

children under 12 years

do not use

Other information

  • each 10 mL contains: sodium 6 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose

Questions or comments?

1-800-719-9260

Principal Display Panel

cring mill

For Ages 12 & Over

Adult Tussin

Cough & Chest Congestion

Cough Suppressant (Dextromethorphan HBr)

Expectorant (Guaifenesin)

Cherry Flavor

Non-Drowsy

Relief of:

-Cough

-Mucus

4 FL OZ (118 mL)

359-jv-adult-tussin
CARING MILL ADULT TUSSIN 
dextromethorphan hbr, guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 81522-359
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)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorRED (clear) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 81522-359-261 in 1 CARTON07/21/202105/31/2023
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 81522-359-341 in 1 CARTON07/21/202105/31/2023
2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01207/21/202105/31/2023
Labeler - FSA Store Inc. (049283340)

Revised: 10/2023
 

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.