Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID f5c57b32-69cb-469e-ad2d-64c00b5e66dc
Route
ORAL
Published
Effective Date 2024-10-14
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 Active Since 2015-08-31

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
DOLLAR GENERAL Adult Cough Relief
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 Years and over

Adult

Cough Relief

Dextromethorphan HBr 15 mg

Cough suppressant

Relieves:

  • Cough
  • Minor throat and bronchial irritation
  • impulse to cough

6-8 Hour Relief

Alcohol free

FL OZ (mL)

Orange flavor

Dosing Cup Included

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 DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Questilons Or Comments?

Call 1-888-309-9030

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 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
  • 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
DOLLAR GENERAL Adult Cough Relief
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 Years and over

Adult

Cough Relief

Dextromethorphan HBr 15 mg

Cough suppressant

Relieves:

  • Cough
  • Minor throat and bronchial irritation
  • impulse to cough

6-8 Hour Relief

Alcohol free

FL OZ (mL)

Orange flavor

Dosing Cup Included

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 DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Questilons Or Comments? (Questilons or comments?)

Call 1-888-309-9030

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 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)
  • 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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