Discount Drug Mart Night Time Multi-symptom Cold & Flu Relief

Discount Drug Mart Night Time Multi-symptom Cold & Flu Relief
SPL v4
SPL
SPL Set ID 8148c2b1-f6ec-4597-8e18-a6597cda5705
Route
ORAL
Published
Effective Date 2023-11-17
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 Fd&c Blue No. 1 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Sorbitol Solution Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 603 Shape: oval Color: green Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-08

Description

Drug Facts Active Ingredients (In each softgel) Acetaminophen            325 mg Dextromethorphan HBr  15 mg Doxylamine succinate  6.25 mg


Medication Information

Warnings and Precautions

Warnings

Liver warning:This product contains acetaminophen.

Severe liver damage may occur if you take:

• more than 8 Liquid Caps in 24 hours, which is the maximum daily

amount for this product • with other drugs containing acetaminophen

• 3 or more alcoholic drinks daily 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, lasts for more than

2 days, occurs with or is followed by fever, headache, rash,

nausea or vomiting, consult a doctor promptly.

Indications and Usage

Uses Temporarily relieves common cold and flu symptoms:

• cough due to minor throat and bronchial irritation

• sore throat

• minor aches and pain

• fever

• runny nose and sneezing

Dosage and Administration

Directions

• take only as directed (see Warning)

• do not exceed 4 doses per 24 hours

 Adults and Children 12 yrs & over  2 softgels with water every 6 hours
 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

Description

Drug Facts Active Ingredients (In each softgel) Acetaminophen            325 mg Dextromethorphan HBr  15 mg Doxylamine succinate  6.25 mg

Section 50565-1

Keep out of reach of children.In case of accidental 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.

Section 50566-9

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.

Section 50567-7

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, and tranquilizers may increase drowsiness

Section 50568-5

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers

• taking the blood thinning drug warfarin

Section 50569-3

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 an enlarged prostate gland

Section 50570-1

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

Section 51727-6

Inactive ingredients D&C Yellow # 10, FD&C Blue # 1,

Gelatin, glycerin, Polyethylene glycol, Povidone, Propylene Glycol,

Purified water, Sorbitol sorbitan solution, Titanium dioxide.

Section 53413-1

Questions?Call Weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Section 53414-9

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

Section 55105-1

Purpose

Acetaminophen                    Pain reliever/Fever reducer

Dextromethorphan HBr         Cough suppressant

Doxylamine succinate           Antihistamine

Section 55106-9

Drug Facts

Active Ingredients (In each softgel)

Acetaminophen            325 mg

Dextromethorphan HBr  15 mg

Doxylamine succinate  6.25 mg

Section 60561-8

Other information

• store at room temperature 20-2S·C (68-77"F)

• avoid excessive heat

Package Labeling: Discount Drug Mart Night Time Multi Symptom Cold & Flu Relief

DISCOUNT                                                                  NDC-53943-603-03

drug mart

FOOD MARKET

Cold &

Flu Relief

MULTI-SYMPTOM

NIGHT TIME

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

24 Softgels

DISTRIBUTED BY:

DRUG MART - FOOD FAIR

211 COMMERCE DRIVE

MEDINA, OH 44256

www.discount-drugmart.com

This product is not manufactured or distributed by Procter

& Gamble, owner of the registered trademark Vicks ®

DayOuil TMLiquiCapsT M

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO STORE

WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON

FOR DISSATISFACTION , NAME, ADDRESS AND EMPTY PACKAGE TO:

DISCOUNT DRUG MART, 211 COMMERCE DRIVE MEDINNA, OHIO 44256


Structured Label Content

Indications and Usage (34067-9)

Uses Temporarily relieves common cold and flu symptoms:

• cough due to minor throat and bronchial irritation

• sore throat

• minor aches and pain

• fever

• runny nose and sneezing

Dosage and Administration (34068-7)

Directions

• take only as directed (see Warning)

• do not exceed 4 doses per 24 hours

 Adults and Children 12 yrs & over  2 softgels with water every 6 hours
 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

Warnings and Precautions (34071-1)

Warnings

Liver warning:This product contains acetaminophen.

Severe liver damage may occur if you take:

• more than 8 Liquid Caps in 24 hours, which is the maximum daily

amount for this product • with other drugs containing acetaminophen

• 3 or more alcoholic drinks daily 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, lasts for more than

2 days, occurs with or is followed by fever, headache, rash,

nausea or vomiting, consult a doctor promptly.

Section 50565-1 (50565-1)

Keep out of reach of children.In case of accidental 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.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

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, and tranquilizers may increase drowsiness

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers

• taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

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 an enlarged prostate gland

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients D&C Yellow # 10, FD&C Blue # 1,

Gelatin, glycerin, Polyethylene glycol, Povidone, Propylene Glycol,

Purified water, Sorbitol sorbitan solution, Titanium dioxide.

Section 53413-1 (53413-1)

Questions?Call Weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Acetaminophen                    Pain reliever/Fever reducer

Dextromethorphan HBr         Cough suppressant

Doxylamine succinate           Antihistamine

Section 55106-9 (55106-9)

Drug Facts

Active Ingredients (In each softgel)

Acetaminophen            325 mg

Dextromethorphan HBr  15 mg

Doxylamine succinate  6.25 mg

Section 60561-8 (60561-8)

Other information

• store at room temperature 20-2S·C (68-77"F)

• avoid excessive heat

Package Labeling: Discount Drug Mart Night Time Multi Symptom Cold & Flu Relief (Package Labeling: DISCOUNT drug mart Night Time Multi-Symptom Cold & Flu Relief)

DISCOUNT                                                                  NDC-53943-603-03

drug mart

FOOD MARKET

Cold &

Flu Relief

MULTI-SYMPTOM

NIGHT TIME

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

24 Softgels

DISTRIBUTED BY:

DRUG MART - FOOD FAIR

211 COMMERCE DRIVE

MEDINA, OH 44256

www.discount-drugmart.com

This product is not manufactured or distributed by Procter

& Gamble, owner of the registered trademark Vicks ®

DayOuil TMLiquiCapsT M

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO STORE

WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON

FOR DISSATISFACTION , NAME, ADDRESS AND EMPTY PACKAGE TO:

DISCOUNT DRUG MART, 211 COMMERCE DRIVE MEDINNA, OHIO 44256


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