DRX CHOICE FRUIT PUNCH- guaifenesin syrup 
Raritan Pharmaceuticals Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRx. Adult Cough Syrup for Adults Drug Facts

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

DRx Choice Adult Cough Syrup Fruit Punch Flavor
DRX CHOICE  FRUIT PUNCH
guaifenesin syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-743
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorREDScore    
ShapeSize
FlavorFRUIT PUNCH (Naturally and Artificially) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68163-743-041 in 1 CARTON05/15/2019
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/15/2019
Labeler - Raritan Pharmaceuticals Inc (127602287)

Revised: 9/2023
Document Id: 20dc7a0b-4e2c-4743-87f9-5bafffdbf003
Set id: a19d7e1c-c04e-41c6-8af6-ecde96299216
Version: 5
Effective Time: 20230902
 
Raritan Pharmaceuticals Inc