Nighttime Cold And Flu

SPL v3

SPL

SPL Set ID 1deb60f3-e9be-4756-b0c1-527ef00dc741

Route

ORAL

Published

Effective Date 2024-10-24

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

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

Identifiers & Packaging

Pill Appearance

Imprint: Q07 Shape: oval Color: green Size: 20 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-07-12

Description

Active ingredients (in each capsule) Acetaminophen USP 325 mg Dextromethorphan HBr USP 15 mg Doxylamine succinate USP 6.25 mg

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine

Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Description

Active ingredients (in each capsule) Acetaminophen USP 325 mg Dextromethorphan HBr USP 15 mg Doxylamine succinate USP 6.25 mg

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 4 doses in 24 hrs, which is the maximum daily amount for this product
with other drugs containing acetaminophen
3 or more alcoholic drinks daily while using this product

Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

Directions

take only as directed – see Overdose warning
do not exceed 4 doses per 24 hours

adults & children 12 yrs & over	2 capsules with water every 6 hrs
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

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.
to make a child sleep

Drug Facts

Active ingredients (in each capsule)

Acetaminophen USP 325 mg

Dextromethorphan HBr USP 15 mg

Doxylamine succinate USP 6.25 mg

Other Information

store at room temperature

Inactive Ingredients

D&C Yellow No. 10, gelatin, glycerin, Neelicert FD&C Blue No. 1, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments?

call 1-855-274-4122

Distributed by :

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, Pa 19087

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.

Overdose warning:

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

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

Package Label Principal Display Panel 16 Cpsules Bottle

NDC 68016-878-16

Premier Value ^®

COMPARE TO THE ACTIVE INGREDIENTS

IN VICKS^® NYQUIL^® COLD & FLU

NIGHTTIME RELIEF LIQUICAPS^®

Multi-Symptom

Nighttime

COLD & FLU RELIEF

Acetaminophen, Dextromethorphan HBr and

Doxylamine Succinate Capsules

325 mg/15 mg/6.25 mg

Aches, Fever & Sore Throat
Sneezing, Runny Nose
Cough

16 Capsules

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

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 4 doses in 24 hrs, which is the maximum daily amount for this product
with other drugs containing acetaminophen
3 or more alcoholic drinks daily while using this product

Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

Directions

take only as directed – see Overdose warning
do not exceed 4 doses per 24 hours

adults & children 12 yrs & over	2 capsules with water every 6 hrs
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

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.
to make a child sleep

Drug Facts

Active ingredients (in each capsule)

Acetaminophen USP 325 mg

Dextromethorphan HBr USP 15 mg

Doxylamine succinate USP 6.25 mg

Other Information (Other information)

store at room temperature

Inactive Ingredients (Inactive ingredients)

D&C Yellow No. 10, gelatin, glycerin, Neelicert FD&C Blue No. 1, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments? (Questions or comments?)

call 1-855-274-4122

Distributed by :

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, Pa 19087

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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

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

Package Label Principal Display Panel 16 Cpsules Bottle (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 16 Cpsules Bottle)

NDC 68016-878-16

Premier Value ^®

COMPARE TO THE ACTIVE INGREDIENTS

IN VICKS^® NYQUIL^® COLD & FLU

NIGHTTIME RELIEF LIQUICAPS^®

Multi-Symptom

Nighttime

COLD & FLU RELIEF

Acetaminophen, Dextromethorphan HBr and

Doxylamine Succinate Capsules

325 mg/15 mg/6.25 mg

Aches, Fever & Sore Throat
Sneezing, Runny Nose
Cough

16 Capsules

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", "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 4 doses in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.", "Directions": "take only as directed – see Overdose warning do not exceed 4 doses per 24 hours adults & children 12 yrs & over 2 capsules with water every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing", "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. to make a child sleep", "Drug Facts": "Active ingredients (in each capsule) Acetaminophen USP 325 mg Dextromethorphan HBr USP 15 mg Doxylamine succinate USP 6.25 mg", "Other information": "store at room temperature", "Inactive ingredients": "D&C Yellow No. 10, gelatin, glycerin, Neelicert FD&C Blue No. 1, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, sorbitol sorbitan solution, titanium dioxide", "Questions or comments?": "call 1-855-274-4122 Distributed by : Pharmacy Value Alliance, LLC 407 East Lancaster Avenue, Wayne, Pa 19087", "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.": "Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.", "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", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 16 Cpsules Bottle": "NDC 68016-878-16 Premier Value ® COMPARE TO THE ACTIVE INGREDIENTS IN VICKS ® NYQUIL ® COLD & FLU NIGHTTIME RELIEF LIQUICAPS ® Multi-Symptom Nighttime COLD & FLU RELIEF Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate Capsules 325 mg/15 mg/6.25 mg Aches, Fever & Sore Throat Sneezing, Runny Nose Cough 16 Capsules"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:58.507626 · Updated: 2026-03-14T23:04:21.109870