premier value tussin cough log-acting drug facts

premier value tussin cough log-acting drug facts
SPL v6
SPL
SPL Set ID 0e393287-5bb8-458b-98c4-55fa16674d06
Route
oral
Published
Effective Date 2024-10-28
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 2019-05-23

Purpose

Cough suppressant

Description

Dextromethorphan HBr, USP 30 mg


Medication Information

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Purpose

Cough suppressant

Directions
  • shake well before using
  • 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 

Other Information
  • store between 20-25°C (68-77°F)
  • Do not refrigerate
  • Alcohol-free
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

Description

Dextromethorphan HBr, USP 30 mg

Principal Display Panel

Premier Value®

NDC# 68016-742-04

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

Tussin Cough Long-acting

Cough Suppressant

Dextromethorphan HBr

Controls Coughs

8 Hour Relief

Non-Drowsy

For Ages 12 & Over

4 FL OZ (118mL)

*This product is not manufactured or distributed by Wyeth Consumer Healthcare, distributors of Robitussin® Lingering Cold Long-Acting Cough.

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

PARENTS: Learn about teen medicine abuse   www.StopMedicineAbuse.org

DISTRIBUTED BY

CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD

SUITE 101, BOCA RATON, FL 33431

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.

Questions Or Comments?

1-866-467-2748

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
  • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Purpose

Cough suppressant

Directions
  • shake well before using
  • 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 

Other Information (Other information)
  • store between 20-25°C (68-77°F)
  • Do not refrigerate
  • Alcohol-free
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

Principal Display Panel

Premier Value®

NDC# 68016-742-04

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

Tussin Cough Long-acting

Cough Suppressant

Dextromethorphan HBr

Controls Coughs

8 Hour Relief

Non-Drowsy

For Ages 12 & Over

4 FL OZ (118mL)

*This product is not manufactured or distributed by Wyeth Consumer Healthcare, distributors of Robitussin® Lingering Cold Long-Acting Cough.

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

PARENTS: Learn about teen medicine abuse   www.StopMedicineAbuse.org

DISTRIBUTED BY

CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD

SUITE 101, BOCA RATON, FL 33431

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.

Questions Or Comments? (Questions or comments?)

1-866-467-2748

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

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