Drx. Adult Cough Syrup For Adults Drug Facts

Drx. Adult Cough Syrup For Adults Drug Facts
SPL v7
SPL
SPL Set ID a19d7e1c-c04e-41c6-8af6-ecde96299216
Route
ORAL
Published
Effective Date 2025-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (200 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

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-05-15

Description

Guaifenesin, USP 200 mg

Purpose

Expectorant


Medication Information

Purpose

Expectorant

Description

Guaifenesin, USP 200 mg

Use

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

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
  • 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 – 20 mL every 4 hours

children under 12 years

do not use

Other Information
  • each 10 mL contains:sodium 4 mg
  • store at room temperature
Inactive Ingredients

anhydrous citric acid, disodium edetate, FD&C red no. 40, flavor, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Principal Display Panel

DRx CHOICE ®

NDC# 68163-743-04

Compare to the active ingredient in Robitussin ®Mucus + Chest Congestion*

Adult Cough Syrup

Guaifenesin (Expectorant)

Relieves:

  • Mucus
  • Chest congestion

Sugar-Free

ORIGINAL

Fruit Punch Flavor

Naturally and Artificially Flavored

For Ages 12 & Over

4 FL OZ (118 mL)

IMPORTANT:Keep this carton for future reference on full labeling.

*This product is not manufactured or distributed by Pfizer, owner of the registered trademark Robitussin ®Mucus + Chest Congestion.

Manufactured by:

Raritan Pharmaceuticals

8 Joanna Court,

East Brunswick, NJ 08816

Stop Use and Ask A Doctor If

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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)

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

Structured Label Content

Use

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Purpose

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
  • 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 – 20 mL every 4 hours

children under 12 years

do not use

Other Information (Other information)
  • each 10 mL contains:sodium 4 mg
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, disodium edetate, FD&C red no. 40, flavor, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Principal Display Panel

DRx CHOICE ®

NDC# 68163-743-04

Compare to the active ingredient in Robitussin ®Mucus + Chest Congestion*

Adult Cough Syrup

Guaifenesin (Expectorant)

Relieves:

  • Mucus
  • Chest congestion

Sugar-Free

ORIGINAL

Fruit Punch Flavor

Naturally and Artificially Flavored

For Ages 12 & Over

4 FL OZ (118 mL)

IMPORTANT:Keep this carton for future reference on full labeling.

*This product is not manufactured or distributed by Pfizer, owner of the registered trademark Robitussin ®Mucus + Chest Congestion.

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 for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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))

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

Advanced Ingredient Data


Raw Label Data

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