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

Purpose

Expectorant

Description

Guaifenesin, USP 200 mg


Medication Information

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
  • 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.

Description

Guaifenesin, USP 200 mg

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

Use

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

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

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

Use

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

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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