DRX CHOICE NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled

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]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each softgel)

Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

• ▪ cough due to minor throat & bronchial irritation
• ▪ sore throat
• ▪ headache
• ▪ minor aches & pains
• ▪ fever
• ▪ runny nose & sneezing

Warnings

•   Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• ▪ more than 8 softgels in 24 hours, which is the maximum daily amount for this product
• ▪ with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product

Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• ▪ skin reddening
• ▪ blisters
• ▪ rash

If a skin reaction occurs, stop use and seek medical help right away
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

• ▪ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• ▪ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• ▪ liver disease
• ▪ glaucoma
• ▪ cough that occurs with too much phlegm (mucus)
• ▪ a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
• ▪ trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

• ▪ taking sedatives or tranquilizers
• ▪ taking the blood thinning drug warfarin

When using this product

• ▪ do not use more than directed
• ▪ excitability may occur, especially in children
• ▪ marked drowsiness may occur
• ▪ avoid alcoholic drinks
• ▪ be careful when driving a motor vehicle or operating machinery
• ▪ alcohol, sedatives, & tranquilizers may increase drowsiness

Stop use and ask a doctor if

• ▪ pain or cough gets worse or lasts more than 7 days
• ▪ fever gets worse or lasts more than 3 days
• ▪ redness or swelling is present
• ▪ new symptoms occur
• ▪ cough comes back or occurs with rash or headache that lasts. These could be signs 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• ▪ take only as directed
• ▪ do not exceed 8 softgels per 24 hrs

• adults & children 12 yrs & over:

  2 softgels with water every 6 hrs

• children 4 to under 12 yrs:

  ask a doctor

• children under 4 yrs:

  do not use

Other information

• store at room temperature

Inactive ingredients

FD&C Blue No. 1, D&C Yellow No. 10, gelatin, glycerin, polyethylene glycol 400, polyvinyl pyrrolidone, propylene glycol, sorbitol sorbitan anhydrous, titanium dioxide

Questions or comments?

1-866-467-2748

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: This package is safety-sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.

SPL UNCLASSIFIED SECTION

Distributed by:
Raritan Pharmaceuticals
8 Joanna Court

East Brunswick, NJ 08816

PRINCIPAL DISPLAY PANEL

*Compare to the active ingredients in Vicks® NyQuil™ Cold & Flu LiquiCaps™

DRx Choice®

Nighttime

Cold & flu relief

Acetaminophen – Pain Reliever/Fever Reducer

Doxylamine Succinate – Antihistamine

Dextromethorphan HBr – Cough Suppressant

Headache, Fever, Sore Throat, Minor Aches & Pains

Sneezing, Runny Nose, Cough

10 softgels

INGREDIENTS AND APPEARANCE

DRX CHOICE  NIGHTTIME COLD AND FLU RELIEF
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68163-062
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	GREEN	Score	no score
Shape	OVAL	Size	21mm
Flavor		Imprint Code	RP062
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68163-062-10	5 in 1 CARTON	12/01/2025
1		2 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	12/01/2025

Labeler - Raritan Pharmaceuticals Inc. (127602287)