Guaifenesin and Dextromethorphan Hydrobromide by LLC Federal Solutions / Safecor Health, LLC

Guaifenesin and Dextromethorphan Hydrobromide by

Drug Labeling and Warnings

Guaifenesin and Dextromethorphan Hydrobromide by is a Otc medication manufactured, distributed, or labeled by LLC Federal Solutions, Safecor Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE- guaifenesin and dextromethorphan hydrobromide liquid 
LLC Federal Solutions

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.

----------

Active Ingredient:
Guaifenesin 100 mg (in each 5 mL (teaspoon)(TSP))

Active Ingredient:
Dextromethorphan HBr 10 mg (in each 5 mL (teaspoon)(TSP))

Purpose of Guaifenesin:
Expectorant

Purpose of Dextromethorphan HBr:
Cough Suppressant

Uses

• temporarily relieves cough due to minor throat and bronchial irritation
• helps loosen phlegm (mucus)
• thin bronchial secretions to make coughs more productive

Warnings
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• persistent cough or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema
• cough accompanied by excessive phlegm (mucus)

Stop use and ask a doctor if

• cough lasts more than 7 days or occurs with fever, rash, or headaches that lasts. This could be signs of a serious condition
• hypersensitive to any ingredients

If pregnant or breast-feeding, ask a health professional before use.

Keep this and all drugs out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• take every 4 hours, or as directed by a doctor
• do not take more than 6 doses in 24 hours

• Adult and children 12 years and over: 2 teaspoonfuls (TSP)
• Children under 12 years: DO NOT USE

Other information
Store at room temperature between 15°-30°C (59°-86°F)
Does not cause drowsiness

Inactive ingredients
citric acid, strawberry flavor, glycerin, menthol, methylparaben, propylene glycol, saccharin sodium, sodium benzoate, sorbitol, water.

Questions
Call 1-855-333-6337

Repackaged by:
Safecor Health, LLC
317 New Boston St.
Woburn, MA 01801

Distributed by:
LLC Federal Solutions
14 NE 1st Ave.
Miami, FL 33132

Rev 102-00 07/2013

———PRINCIPAL DISPLAY PANEL———
NDC: 24451-133-05
guaiFENesin AND
DEXTROMETHORPHAN HBr
100 mg / 10 mg PER 5 mL
(SILTUSSIN-DM DAS COUGH FORMULA)
DELIVERS 5 mL
ALCOHOL /DYE/ SUGAR FREE
STRAWBERRY FLAVOR
Exp: 00/00/00       Lot # 00000

Rpk By: Safecor Health LLC
Woburn, MA 01801
Dist. By: LLC Federal Solutions
Miami, FL 33132

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 
guaifenesin and dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24451-133(NDC: 54838-133)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24451-133-05	100 in 1 BOX	08/08/2013	12/31/2019
1		5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 24451-133-10	100 in 1 BOX	08/08/2013	12/31/2019
2		10 mL in 1 CUP, UNIT-DOSE; 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	08/08/2013	12/31/2019

Labeler - LLC Federal Solutions (965036895)

Establishment
Name	Address	ID/FEI	Business Operations
Safecor Health, LLC		828269675	repack(24451-133)

Revised: 1/2020

Document Id: 2a09d812-cf0b-40d3-a116-d5d760cb6d1e

34390-5

Set id: a9386499-40d2-4a92-ae26-6d326472fffc

Version: 2

Effective Time: 20200107