DELSYM- dextromethorphan suspension, extended release

Delsym by

Drug Labeling and Warnings

Delsym by is a Otc medication manufactured, distributed, or labeled by ATLANTIC BIOLOGICALS CORP.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

Purpose

Cough suppressant

Uses

temporarily relieves

• cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
• the impulse to cough to help you get to sleep

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

• chronic cough that lasts as occurs with smoking, asthma or emphysema
• cough that occurs with too much phlegm (mucus)

Stop use and ask a doctor if cough lasts more than 7 days, cough 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

• shake bottle well before use
• measure only with dosing cup provided
• do not use dosing cup with other products
• dose as follows or as directed by a doctor
• mL = milliliter

• adults and children 12 years of age and over: 10 mL every 12 hours, ; not to exceed 20 mL in 24 hours
• children 6 to under 12 years of age: 5 mL every 12 hours, ; not to exceed 10 mL in 24 hours
• children 4 to under 6 years of age: 2.5 mL every 12 hours,; not to exceed 5 mL in 24 hours
• children under 4 years of age: do not use

Other information

• each 5 mL contains: sodium 7 mg
• store at 20-25°C (68-77°F)
• dosing cup provided

Inactive ingredients

citric acid anhydrous, D&C red no. 33, edetate disodium, ethylcellulose, FD&C blue no. 1, flavor, high fructose corn syrup, methylparaben, partially hydrogenated vegetable oil (soybean, cottonseed), polyethylene glycol 3350, polysorbate 80, propylene glycol, propylparaben, purified water, sucrose, tragacanth, xanthan gum

Questions?

1-866-682-4639
You may also report side effects to this phone number.

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DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP. 

20101 N.E 16TH PLACE

MIAMI, FL 33179

NDC:

17856-0172-01Delsym® Dextromethorphan PolistirexExtended-Release Suspension (Cough Suppressant) COUGH 12HOURCOUGH RELIEF® GrapeFlavored Liquid 10mL CUP 72 PER CASE Day or NightSULFITE FREEALCOHOL FREE

INGREDIENTS AND APPEARANCE

DELSYM 
dextromethorphan suspension, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17856-0172(NDC:63824-171)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextromethorphan (UNII: 7355X3ROTS) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	30 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
Polistirex (UNII: 5H9W9GTW27)
anhydrous citric acid (UNII: XF417D3PSL)
D&C Red NO. 33 (UNII: 9DBA0SBB0L)
edetate disodium (UNII: 7FLD91C86K)
ethylcellulose, unspecified (UNII: 7Z8S9VYZ4B)
FD&C Blue NO. 1 (UNII: H3R47K3TBD)
high fructose corn syrup (UNII: XY6UN3QB6S)
methylparaben (UNII: A2I8C7HI9T)
polyethylene glycol 3350 (UNII: G2M7P15E5P)
polysorbate 80 (UNII: 6OZP39ZG8H)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
sucrose (UNII: C151H8M554)
tragacanth (UNII: 2944357O2O)
xanthan gum (UNII: TTV12P4NEE)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17856-0172-1	72 in 1 BOX, UNIT-DOSE	12/17/2018
1		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
NDA	NDA018658	12/17/2018

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
ATLANTIC BIOLOGICALS CORP.		047437707	repack(17856-0172) , relabel(17856-0172)