drug facts

drug facts
SPL v6
SPL
SPL Set ID 13ae4c67-a3fe-440c-91b8-c9412626c3cd
Route
oral
Published
Effective Date 2024-04-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (15 mg)
Inactive Ingredients
anhydrous citric acid edetate disodium glycerin high fructose corn syrup propylene glycol water sodium benzoate sucralose sucrose xanthan gum fd&c yellow no. 6 hydroxyethyl cellulose (1500 mpa.s at 1%) polyethylene glycol, unspecified

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2015-07-31

Purpose

Cough suppressant

Description

Dextromethorphan HBr 15 mg


Medication Information

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
Purpose

Cough suppressant

Directions
  • take recommended dosage or as directed by a doctor
  • measure only with dosing cup provided. Do not use any other dosing device
  • keep dosing cup with product
  • shake well before using
  • mL = milliliter
age  dose
 adults and children 12 years and over  10 mL every 6-8 hours no to exceed 4 doses in 24 hours
 children 6 to 11 years of age  5 mL every 6-8 hours not to exceed 4 doses in 24 hours
 children under 6 years of age  do not use


Other Information
  • each 5 mL contains: sodium 3 mg
  • store between 20-25º C (68-77ºF). Do not refrigerate.
Inactive Ingredients

anhydrous citric acid, edetate disodium, FD&C yellow #6 flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sucralose, sucrose, xanthan gum

Description

Dextromethorphan HBr 15 mg

Principal Display Panel

COUGH RELIEF

Cough Suppressant

Dextromehtorphan HBr 15 mg

Cough Suppressant

For Ages 6 & Over

6-8 Hour Relief

Alcohol Free

Orange Flavor

FL OZ (mL)

Contains no fever reducer or pain reliever

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

Distributed by C.D.M.A., Inc,©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

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.
Package Label
QUALITY CHOICE Cough Relief
Questions Or Comments?

Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

When Using This Product
  • do not use more than directed
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 (1-800-222-1222) right away.

Active Ingredient (in Each 5 Ml)

Dextromethorphan HBr 15 mg

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)

Structured Label Content

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
Purpose

Cough suppressant

Directions
  • take recommended dosage or as directed by a doctor
  • measure only with dosing cup provided. Do not use any other dosing device
  • keep dosing cup with product
  • shake well before using
  • mL = milliliter
age  dose
 adults and children 12 years and over  10 mL every 6-8 hours no to exceed 4 doses in 24 hours
 children 6 to 11 years of age  5 mL every 6-8 hours not to exceed 4 doses in 24 hours
 children under 6 years of age  do not use


Other Information (Other information)
  • each 5 mL contains: sodium 3 mg
  • store between 20-25º C (68-77ºF). Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, edetate disodium, FD&C yellow #6 flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sucralose, sucrose, xanthan gum

Principal Display Panel

COUGH RELIEF

Cough Suppressant

Dextromehtorphan HBr 15 mg

Cough Suppressant

For Ages 6 & Over

6-8 Hour Relief

Alcohol Free

Orange Flavor

FL OZ (mL)

Contains no fever reducer or pain reliever

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

Distributed by C.D.M.A., Inc,©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Do Not Use (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.
Package Label
QUALITY CHOICE Cough Relief
Questions Or Comments? (Questions or comments?)

Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

When Using This Product (When using this product)
  • do not use more than directed
Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Dextromethorphan HBr 15 mg

Ask A Doctor Before Use If You Have (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)

Advanced Ingredient Data


Raw Label Data

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