GUIATUSS- guaifenesin syrup
Lake Erie Medical DBA Quality Care Products LLC

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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Guiatuss Syrup

Drug Facts

Active ingredient (in each teaspoonful (5 mL))

Guaifenesin USP 100 mg

Purpose

Expectorant

Use

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

Warnings

Do not use in a child under 12 years

Ask a doctor before use if you have

cough that occurs with too much phlegm (mucus)
cough that lasts or is a chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. 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.

Directions

do not take more than 6 doses in any 24-hour period

adults and children 12 years and older	2 to 4 teaspoons every 4 hours
children under 12 years	do not use

Other information

each teaspoonful (5 mL) contains: sodium 3 mg
store at 20°-25°C (68°-77°F)

Inactive ingredients

caramel powder, citric acid, corn syrup, FD&C Red #40, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium saccharin

Questions?

call 1-888-838-2872, weekdays, 8 AM - 5 PM Eastern Time

Image of Label

GUIATUSS
guaifenesin syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49999-192(NDC:0182-0259)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	100 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
caramel (UNII: T9D99G2B1R)
citric acid monohydrate (UNII: 2968PHW8QP)
corn syrup (UNII: 9G5L16BK6N)
FD&C RED NO. 40 (UNII: WZB9127XOA)
glycerin (UNII: PDC6A3C0OX)
menthol (UNII: L7T10EIP3A)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
sodium benzoate (UNII: OJ245FE5EU)
saccharin sodium (UNII: SB8ZUX40TY)

Product Characteristics
Color	RED (Reddish-Brown)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49999-192-04	118 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package	03/12/2012	11/11/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	03/12/2012	11/11/2013

Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)

Name	Address	ID/FEI	Business Operations
Establishment
Lake Erie Medical DBA Quality Care Products LLC		831276758	relabel(49999-192)

Revised: 12/2016

Document Id: f9faf242-621d-4677-8171-87c578877c7f

Set id: d9db4380-bb6b-4e07-b633-860945d30fc2

Version: 3637

Effective Time: 20161214

Lake Erie Medical DBA Quality Care Products LLC