SUNMARK TUSSIN- guaifenesin solution

sunmark tussin by

Drug Labeling and Warnings

sunmark tussin by is a Otc medication manufactured, distributed, or labeled by Central Texas Community Health Centers. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 20-25°C (68-77°F). 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 - 118 mL Bottle Carton Label

CommUnityCare Federally Qualified Health Centers

TUSSIN
118ml

Date:

Dr.

Name:

TAKE AS DIRECTED.

123456

1/1/01

TUSSIN 118ml NDC: 76413-328-01
Batch: 123456
Lot: 123456
Exp: 1/1/01
SUNMARK
Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

INGREDIENTS AND APPEARANCE

SUNMARK TUSSIN 
guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76413-328(NDC:49348-135)
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
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, UNSPECIFIED FORM (UNII: L7T10EIP3A)

Product Characteristics
Color	RED (dark)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76413-328-01	1 in 1 CARTON	09/17/2014
1		118 mL in 1 BOTTLE, PLASTIC; 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	09/17/2014

Labeler - Central Texas Community Health Centers (079674019)

Establishment
Name	Address	ID/FEI	Business Operations
Central Texas Community Health Centers		079674019	REPACK(76413-328) , RELABEL(76413-328)