Delsym12 Hour Cough Relief: Package Insert / Prescribing Information - Drugs.com

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# Delsym12 Hour Cough Relief

Package insert / prescribing information
Generic name: dextromethorphan
Dosage form: extended-release suspension
Drug class: Antitussives

Medically reviewed by Drugs.com. Last updated on Sep 21, 2022.

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 such 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, 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:
RB Health (US)
Parsippany, NJ
07054-0224

## PRINCIPAL DISPLAY PANEL - 148 mL Bottle Carton

NDC 63824-171-65

Delsym®

Dextromethorphan Polistirex
Extended-Release Suspension (Cough Suppressant)

COUGH

12
HOUR
COUGH RELIEF®

Day or Night

Grape
Flavored Liquid

148 mL (5 fl oz)

SULFITE FREE
ALCOHOL FREE

DELSYM dextromethorphan suspension, extended release

Product Information
Product Type | HUMAN OTC DRUG | Item Code (Source) | 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
1 | NDC:63824-171-63 | 1 BOTTLE in 1 CARTON
1 |  | 89 mL in 1 BOTTLE
2 | NDC:63824-171-65 | 1 BOTTLE in 1 CARTON
2 |  | 148 mL in 1 BOTTLE
3 | NDC:63824-171-75 | 1 BOTTLE in 1 CARTON
3 |  | 15 mL in 1 BOTTLE
4 | NDC:63824-171-22 | 2 CARTON in 1 CELLO PACK
4 |  | 1 BOTTLE in 1 CARTON
4 |  | 148 mL in 1 BOTTLE

Marketing Information
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date
NDA | NDA018658 | 05/04/2010 |

Labeler - RB Health (US) LLC (081049410)

RB Health (US) LLC

## Frequently asked questions

- Delsym 12 Hour Cough Relief. Can I give a small dose of this medicine to my child?
- Dextromethorphan - can you give TusQ Dx to a child and what is the dose?

## More about Delsym 12 Hour Cough Relief (dextromethorphan)

- Check interactions
- Pricing & coupons
- Reviews (39)
- Side effects
- Dosage information
- During pregnancy
- Drug class: antitussives
- Breastfeeding

### Professional resources

- Prescribing Information

### Other formulations

- Delsym
- Delsym Adult Night Time Multi-Symptom

### Related treatment guides

- Cough

Medical Disclaimer