TUSSIN- guaifenesin solution 
Strategic Sourcing Services

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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Tussin
GuaifenesinOral Solution, USP

ACTIVE INGREDIENT(S)


Guaifenesin, USP 200 mg

PURPOSE


Expectorant

USE(S)


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

WHEN USING THIS PRODUCT


■ do not use more than directed

STOP USE AND ASK DOCTOR IF


■ cough lasts more than 7 days, comes back, or occurs with 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

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


Age
Dose
Adults and children
12 years and over
10 – 20 mL
every 4 hours
Children under 12 years
do not use

Other information


each 10 mL contains:sodium 6 mg
■ store between 20-25°C (68-77°F)
■ do not refrigerate
Keep carton for full directions for use

Inactive ingredients


Caramel, citric acid anhydrous, dextrose, FD&C red #40, flavor, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium, sodium benzoate

Questions or comments?

Call 833-358-6431Monday to Friday 9:00am to 7:00pm EST

PRINCIPAL DISPLAY PANEL

Guaifenesin oral solution USP-118 mL

Guaifenesin oral solution USP-118 mL

Guaifenesin oral solution USP-237 mL

Guaifenesin oral solution USP- 237 mL

TUSSIN 
guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-1186
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
CARAMEL (UNII: T9D99G2B1R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
DEXTROSE (UNII: IY9XDZ35W2)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70677-1186-11 in 1 CARTON08/09/2023
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:70677-1186-21 in 1 CARTON08/09/2023
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 finalpart34108/09/2023
Labeler - Strategic Sourcing Services (116956644)
Establishment
NameAddressID/FEIBusiness Operations
AptaPharma Inc.790523323manufacture(70677-1186)

Revised: 8/2023
Document Id: 031e2bbf-f68d-c982-e063-6394a90a6771
Set id: 188f3c82-b4bc-42a5-8068-c2fa0c2ac344
Version: 1
Effective Time: 20230817
 
Strategic Sourcing Services