Drx Choice® Nighttime Cold & Flu

SPL v1

SPL

SPL Set ID f466fc0e-3384-4884-832e-99bf1fdcf899

Route

ORAL

Published

Effective Date 2026-01-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg) Dextromethorphan (15 mg) Doxylamine (6.25 mg)

Inactive Ingredients

Fd&c Blue No. 1 D&c Yellow No. 10 Gelatin, Unspecified Glycerin Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Sorbitol Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: RP062 Shape: oval Color: green Size: 21 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-12-01

Description

Drug Facts

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine

Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Description

Drug Facts

Uses

temporarily relieves common cold/flu symptoms:

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

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.

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

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.

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

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

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.

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

Active Ingredients (in Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Ask A Doctor Or Pharmacist Before Use If You Are

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

Structured Label Content

Uses

temporarily relieves common cold/flu symptoms:

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

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

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

Do Not Use (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.

Other Information (Other information)

•
store at room temperature

Inactive Ingredients (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? (Questions or comments?)

1-866-467-2748

Principal Display Panel (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

When Using This Product (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 (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.

Ask A Doctor Before Use If You Have (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

Active Ingredients (in Each Softgel) (Active ingredients (in each softgel))

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves common cold/flu symptoms: ▪ cough due to minor throat & bronchial irritation ▪ sore throat ▪ headache ▪ minor aches & pains ▪ fever ▪ runny nose & sneezing", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "53414-9": "If pregnant or breast-feeding , ask a health professional before use.", "Purpose": "Pain reliever/fever reducer Cough suppressant Antihistamine", "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.", "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", "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.", "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", "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", "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.", "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", "Active ingredients (in each softgel)": "Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg", "Ask a doctor or pharmacist before use if you are": "▪ taking sedatives or tranquilizers ▪ taking the blood thinning drug warfarin"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:20.301451 · Updated: 2026-03-14T23:12:32.924893