OTC Medication Information: Delsym

DELSYM- dextromethorphan suspension, extended release
ATLANTIC BIOLOGICALS CORP.

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.

DISTRIBUTED BY:


ATLANTIC BIOLOGICALS CORP.

20101 N.E 16TH PLACE

MIAMI, FL 33179

NDC 17856-0172-01Delsym® Dextromethorphan Polistirex
Extended-Release Suspension (Cough Suppressant) COUGH 12 HOUR COUGH RELIEF® Grape Flavored Liquid 10mL CUP 72 PER CASE Day or Night SULFITE FREE ALCOHOL FREE

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextromethorphan (Dextromethorphan) Dextromethorphan Hydrobromide 30 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
Polistirex
anhydrous citric acid
D&C Red NO. 33
edetate disodium
ethylcellulose, unspecified
FD&C Blue NO. 1
high fructose corn syrup
methylparaben
polyethylene glycol 3350
polysorbate 80
propylene glycol
propylparaben
water
sucrose
tragacanth
xanthan gum
Product Characteristics
Color PURPLE Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17856-0172-1 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE contains a CUP, UNIT-DOSE
1 10 mL in 1 CUP, UNIT-DOSE This package is contained within the BOX, UNIT-DOSE (17856-0172-1)
2 NDC:17856-0172-2 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE contains a CUP, UNIT-DOSE
2 5 mL in 1 CUP, UNIT-DOSE This package is contained within the BOX, UNIT-DOSE (17856-0172-2)
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 Operations
ATLANTIC BIOLOGICALS CORP. 047437707 repack (17856-0172), relabel (17856-0172)

Revised: 10/2021 ATLANTIC BIOLOGICALS CORP.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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