Drx Choice Children’s Daytime Cough & Chest Congestion Grape Flavor

Drx Choice Children’s Daytime Cough & Chest Congestion Grape Flavor
SPL v3
SPL
SPL Set ID 25fff2a6-ecb1-4117-bd11-e5ec3e3d09a9
Route
ORAL
Published
Effective Date 2025-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (200 mg)
Inactive Ingredients
Anhydrous Citric Acid Carboxymethylcellulose Sodium, Unspecified Edetate Disodium Glycerin Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-24

Description

Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 200 mg

Purpose

Cough suppressant Expectorant


Medication Information

Purpose

Cough suppressant Expectorant

Description

Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 200 mg

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
Purposes

Cough suppressant

Expectorant

Directions
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter

  Age

Dose

children under 4 years

do not use

children 4 to under 6 years

5 mL every 4 hours

children 6 to under 12 years

10 mL every 4 hours

adults and children 12 years and older

20 mL every 4 hours

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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Other Information
  • each 20 ml contains: sodium 10 mg
  • store at room temperature. Do not refrigerate.
Inactive Ingredients

anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, glycerin, flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum.

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 Ingredients (in Each 20 Ml)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 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, chronic bronchitis, or emphysema
Package Label Principal Display Panel 4 Fl Oz (118 Ml Bottle)

Compare to the active ingredients in Children's Robitussin ®Cough & Chest Congestion DM *

NDC 68163-747-04

DRx Choice®



Children's daytime cough & chest congestion

Dextromethorphan HBr(Cough Suppressant)

Guaifenesin (Expectorant)

Relieves:Chest congestion, mucus & cough

Sugar Free

Dye Free

No Added Alcohol

For Ages 4 & Over



Grape Flavor

Naturally & Artificially Flavored



4 FL OZ (118 mL)

TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING

*This product is not manufactured or distributed by Pfizer, owner of the registered trademarks Children’s Robitussin ®Cough & Chest Congestion DM.

Manufactured by:

Raritan Pharmaceuticals

8 Joanna Court,

East Brunswick,

NJ, 08816






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
Purposes

Cough suppressant

Expectorant

Directions
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter

  Age

Dose

children under 4 years

do not use

children 4 to under 6 years

5 mL every 4 hours

children 6 to under 12 years

10 mL every 4 hours

adults and children 12 years and older

20 mL every 4 hours

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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Other Information (Other information)
  • each 20 ml contains: sodium 10 mg
  • store at room temperature. Do not refrigerate.
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, glycerin, flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum.

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 Ingredients (in Each 20 Ml) (Active ingredients (in each 20 mL))

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 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, chronic bronchitis, or emphysema
Package Label Principal Display Panel 4 Fl Oz (118 Ml Bottle) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL Bottle))

Compare to the active ingredients in Children's Robitussin ®Cough & Chest Congestion DM *

NDC 68163-747-04

DRx Choice®



Children's daytime cough & chest congestion

Dextromethorphan HBr(Cough Suppressant)

Guaifenesin (Expectorant)

Relieves:Chest congestion, mucus & cough

Sugar Free

Dye Free

No Added Alcohol

For Ages 4 & Over



Grape Flavor

Naturally & Artificially Flavored



4 FL OZ (118 mL)

TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING

*This product is not manufactured or distributed by Pfizer, owner of the registered trademarks Children’s Robitussin ®Cough & Chest Congestion DM.

Manufactured by:

Raritan Pharmaceuticals

8 Joanna Court,

East Brunswick,

NJ, 08816






Advanced Ingredient Data


Raw Label Data

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