Drx Choice Long-acting Cough Drug Facts

Drx Choice Long-acting Cough Drug Facts
SPL v3
SPL
SPL Set ID 875b40bd-7955-4048-abbf-7f43d9ea3ac5
Route
ORAL
Published
Effective Date 2023-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (30 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Red No. 40 Potassium Citrate Propylene Glycol Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-24

Description

Dextromethorphan HBr, USP 30 mg

Purpose

Cough suppressant


Medication Information

Purpose

Cough suppressant

Description

Dextromethorphan HBr, USP 30 mg

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
Directions
  • do not take more than 4 doses in a 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • this adult product is not intended for use in children under 12 years of age

age

dose 

 adults and children 12 years and over

10 mL every 6 to 8 hours 

 children under 12 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.

Other Information
  • each 10 ml contains: sodium 3 mg
  • store at room temperature
Inactive Ingredients

anhydrous citric acid, disodium edetate, FD&C red 40, flavor, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments?

1-866-467-2748

Principal Display Panel

*Compare to the active ingredient in Adult Robitussin ®Long-Acting Cough *

NDC 68163-742-04

DRx Choice

long-acting

cough

Dextromethorphan HBr (Cough Suppressant)

Relieves: Cough

8 HOURS RELIEF

No Added Alcohol

Sugar-Free

For Ages 12 & Over

4 FL OZ (118mL)

*This product is not manufactured or distributed by Pfizer, owner of the registered trademark Adult Robitussin® Long-Acting Cough.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING.

IMPORTANT: Keep this carton for future reference for full labelling.

Manufactured by:

Raritan Pharmaceuticals

8 Joanna Court,

East Brunswick,

NJ 08816

Stop Use and Ask A Doctor If

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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 at 1-800-222-1222.

Active Ingredient (in Each 10 Ml)

Dextromethorphan HBr, USP 30 mg

Ask A Doctor Before Use If You Have
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such 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 a cold
Purpose

Cough suppressant

Directions
  • do not take more than 4 doses in a 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • this adult product is not intended for use in children under 12 years of age

age

dose 

 adults and children 12 years and over

10 mL every 6 to 8 hours 

 children under 12 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.

Other Information (Other information)
  • each 10 ml contains: sodium 3 mg
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, disodium edetate, FD&C red 40, flavor, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Principal Display Panel

*Compare to the active ingredient in Adult Robitussin ®Long-Acting Cough *

NDC 68163-742-04

DRx Choice

long-acting

cough

Dextromethorphan HBr (Cough Suppressant)

Relieves: Cough

8 HOURS RELIEF

No Added Alcohol

Sugar-Free

For Ages 12 & Over

4 FL OZ (118mL)

*This product is not manufactured or distributed by Pfizer, owner of the registered trademark Adult Robitussin® Long-Acting Cough.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE IS BROKEN OR MISSING.

IMPORTANT: Keep this carton for future reference for full labelling.

Manufactured by:

Raritan Pharmaceuticals

8 Joanna Court,

East Brunswick,

NJ 08816

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 persistent headache. 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 right away at 1-800-222-1222.

Active Ingredient (in Each 10 Ml) (Active ingredient (in each 10 mL))

Dextromethorphan HBr, USP 30 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)
  • cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)