DRX CHOICE FRUIT PUNCH- guaifenesin syrup

DRx Choice by

Drug Labeling and Warnings

DRx Choice by is a Otc medication manufactured, distributed, or labeled by Raritan Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 10 mL)

Guaifenesin, USP 200 mg

Purpose

Expectorant

Use

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

Warnings

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

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).

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

INGREDIENTS AND APPEARANCE

DRX CHOICE  FRUIT PUNCH
guaifenesin syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68163-743
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	FRUIT PUNCH (Naturally and Artificially)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68163-743-04	1 in 1 CARTON	05/15/2019
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/15/2019

Labeler - Raritan Pharmaceuticals Inc (127602287)