Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID f49f1e9a-07ac-443e-9df8-3281d5f35e78
Route
ORAL
Published
Effective Date 2026-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (15 mg)
Inactive Ingredients
Anhydrous Citric Acid Water Edetate Disodium Fd&c Yellow No. 6 Glycerin High Fructose Corn Syrup Hydroxyethyl Cellulose (1500 Mpa.s At 1%) Polyethylene Glycol, Unspecified Propylene Glycol Sodium Benzoate Sucralose Sucrose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2015-06-30 Until 2027-03-28

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 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


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

anhydrous citric acid, disodium EDTA, 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

For Ages 6 & Over

Cough Relief

DEXTROMETHORPHAN HBr 15 mg

COUGH SUPPRESSANT

6-8 Hour Relief

ORANGE FLAVOR

Alcohol-Free

FL OZ (mL)

Dosing Cup Included

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.

PROUDLY DISTRIBUTED BY:

VALU MERCHANDISERS, CO

5000 KANSAS AVE

KANSAS CITY, KS 66106

When Using This Product,

do not use more than directed

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 (1-800-222-1222) right away.

Active Ingredient (in Each 5 Ml)

Dextromethorphan HBr 15 mg

Ask A Doctor Before Use If You Have
  • cough that occurs with too much phlegm (mucus)
  • chronic cough that lasts as occurs with smoking, asthma, or emphysema

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 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


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 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)

anhydrous citric acid, disodium EDTA, 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

For Ages 6 & Over

Cough Relief

DEXTROMETHORPHAN HBr 15 mg

COUGH SUPPRESSANT

6-8 Hour Relief

ORANGE FLAVOR

Alcohol-Free

FL OZ (mL)

Dosing Cup Included

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.

PROUDLY DISTRIBUTED BY:

VALU MERCHANDISERS, CO

5000 KANSAS AVE

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

Advanced Ingredient Data


Raw Label Data

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