CAREONE ADULT TUSSIN- guaifenesin solution 
American Sales Company

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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American Sales Company Adult Tussin Drug Facts

Active ingredient (in each 10 mL)

Guaifenesin, USP 200 mg

Purpose

Expectorant

Use

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

Warnings

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 – 20 mL every 4 hours

children under 12 years

do not use

Other information

•
store at 20-25oC (68-77oF).

Do not refrigerate.

Inactive ingredients

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

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the Active Ingredient in Robitussin® Mucus + Chest Congestion

ADULT

TUSSIN

EXPECTORANT [Guaifenesin, USP]

MUCUS & CHEST CONGESTION

For Ages 12 and Over

Non-Drowsy

Alcohol Free

Relieves:

Chest Congestion

Mucus

4 FL OZ (118 mL)

CareOne Adult Tussin Image 1
CareOne Adult Tussin Image 2
CAREONE ADULT TUSSIN 
guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-310
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CARAMEL (UNII: T9D99G2B1R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
MALTOL (UNII: 3A9RD92BS4)  
MENTHOL (UNII: L7T10EIP3A)  
Product Characteristics
ColorRED (dark) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-310-261 in 1 CARTON05/04/200408/05/2019
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 finalpart34105/04/200408/05/2019
Labeler - American Sales Company (809183973)

Revised: 12/2019
Document Id: d4832d85-b0e5-4ec4-935a-115dfcc4069e
Set id: 33921304-b258-4b9c-882c-e768cd0c0322
Version: 4
Effective Time: 20191217
 
American Sales Company