Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 204a7fc4-142d-45fd-8a77-0612857132be
Route
ORAL
Published
Effective Date 2025-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (15 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Hydroxyethyl Cellulose (4000 Mpa.s At 1%) Glycerin High Fructose Corn Syrup Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Sucralose Sucrose Xanthan Gum Fd&c Yellow No. 6

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-15

Description

Dextromethorphan HBr 15 mg

Purpose

Cough suppressant


Medication Information

Purpose

Cough suppressant

Description

Dextromethorphan HBr 15 mg

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
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 not to exceed 4 doses in 24 hours

 children 6 to under 11 years  5 mL every 6-8 hours not to exceed 4 doses in 24 hours

 children under 6 years  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
BEST CHOICE Adult Cough Relief Orange Flavor
Other Information
  •  each 5 mL contains: sodium 3 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate
Inactive Ingredients

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

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

ADULT

Cough Relief

DEXTROMETHORPHAN HBr 15 mg

COUGH SUPPRESSANT

For relief of:

  • Cough
  • Minor throat & bronchial irritation
  • Impulse to cough

ORANGE FLAVOR

FOR AGES 6 & OVER

ALCOHOL-FREE

6-8 HOUR RELIEF

FL OZ (mL)

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

PROUDLY DISTRIBUTED BY:

ASSOCIATED WHOLESALE GROCERS, INC.

KANSAS CITY, KANSAS 66106

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 is accompanied by 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 not to exceed 4 doses in 24 hours

 children 6 to under 11 years  5 mL every 6-8 hours not to exceed 4 doses in 24 hours

 children under 6 years  do not use

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
BEST CHOICE Adult Cough Relief Orange Flavor
Other Information (Other information)
  •  each 5 mL contains: sodium 3 mg
  • store between 20-25ºC (68-77ºF). Do not refrigerate
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

ADULT

Cough Relief

DEXTROMETHORPHAN HBr 15 mg

COUGH SUPPRESSANT

For relief of:

  • Cough
  • Minor throat & bronchial irritation
  • Impulse to cough

ORANGE FLAVOR

FOR AGES 6 & OVER

ALCOHOL-FREE

6-8 HOUR RELIEF

FL OZ (mL)

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

PROUDLY DISTRIBUTED BY:

ASSOCIATED WHOLESALE GROCERS, INC.

KANSAS CITY, KANSAS 66106

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 is accompanied by 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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