TUSSIN- guaifenesin solution

Tussin by

Drug Labeling and Warnings

Tussin by is a Otc medication manufactured, distributed, or labeled by Strategic Sourcing Services, AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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-237 mL

INGREDIENTS AND APPEARANCE

TUSSIN 
guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70677-1186
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70677-1186-1	1 in 1 CARTON	08/09/2023
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 70677-1186-2	1 in 1 CARTON	08/09/2023
2		237 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/09/2023

Labeler - Strategic Sourcing Services (116956644)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(70677-1186)