Label: DRX CHOICE FRUIT PUNCH- guaifenesin syrup
- NDC Code(s): 68163-743-04
- Packager: Raritan Pharmaceuticals Inc
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated September 2, 2023
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- Official Label (Printer Friendly)
- Active ingredient (in each 10 mL)
- Purpose
- Use
-
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
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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
- Inactive ingredients
-
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
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INGREDIENTS AND APPEARANCE
DRX CHOICE FRUIT PUNCH
guaifenesin syrupProduct 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)