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NDC 36800-0667-24 SEVERE COLD AND FLU Details

SEVERE COLD AND FLU

SEVERE COLD AND FLU is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by TopCo Associates LLC. The primary component is .

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 36800-0667-24
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Related Packages: 36800-0667-24
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold. Doxylamine should not be used to cause sleepiness in children. Doxylamine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 36800-0667-24
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Doxylamine

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Related Packages: 36800-0667-24
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Related Packages: 36800-0667-24
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	36800-0667
Product ID	36800-667_ee2806c0-83dd-02c5-e053-2a95a90a742f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	SEVERE COLD AND FLU
Proprietary Name Suffix	DAYTIME NON DROWSY NIGHTTIME
Non-Proprietary Name	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE / ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	KIT
Route	n/a
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	TopCo Associates LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 36800-0667-24 (36800066724)

Pricing Information	N/A
NDC Package Code	36800-667-24
Billing NDC	36800066724
Package	1 KIT in 1 PACKAGE, COMBINATION (36800-667-24) * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date	2019-10-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 74c9dd48-4440-4860-9d82-79701d881299 Details

Daytime and Nighttime SEVERE COLD AND FLU

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each softgel) Purposes

Acetaminophen 325 mg............................Pain reliever/fever reducer

Dextromethorphan HBr 10 mg.............................Cough suppressant

Guaifenesin 200 mg.........................................................Expectorant

Phenylephrine HCl 5 mg......................................Nasal decongestant

Uses

■ temporarily relieves common cold/flu symptoms:

■ nasal congestion ■ sinus congestion & pressure

■ cough due to minor throat & bronchial irritation

■ minor aches & pains ■ headache

■ fever ■ sore throat ■ reduces swelling of nasal passages

■ temporarily restores freer breathing through the nose

■ promotes nasal and/or sinus drainage

■ helps loosen phlegm (mucus) and thin bronchial secretions to

rid the bronchial passageways of bothersome mucus and make

coughs more productive.

Warnings

Liver warning This product contains acetaminophen. Severe liver

damage may occur if you take

■ more than 4 doses 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

Drug Facts (continued)

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 ■ heart disease ■ high blood pressure

■ thyroid disease ■ diabetes

■ trouble urinating due to enlarged prostate gland

■ cough that occurs with too much phlegm (mucus)

■ persistent or chronic cough such as occurs with smoking,

asthma, chronic bronchitis, or emphysema

SPL UNCLASSIFIED SECTION

Ask a doctor or pharmacist before use if you are taking the blood

thinning drug warfarin.

SPL UNCLASSIFIED SECTION

When using this product, do not use more than directed.

SPL UNCLASSIFIED SECTION

Drug Facts (continued)

Stop use and ask a doctor if

■ you get nervous, dizzy or sleepless

■ pain, nasal congestion, 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.

SPL UNCLASSIFIED SECTION

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. 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 - see Overdose warning

■ do not exceed 4 doses per 24 hours


adults & children 12 years & over	2 softgels with water every 4 hours
children 4 to under 12 years	ask a doctor
children under 4 years	do not use

■ when using other Nighttime or Daytime products, carefully read

each label to ensure correct dosing

Other information

■ store at room temperature

Inactive ingredients

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

SPL UNCLASSIFIED SECTION

NIGHTTIME SEVERE COLD & FLU SOFTGELS

Drug Facts

Active ingredients (in each softgel) Purposes

Acetaminophen 325 mg............................Pain reliever/fever reducer

Dextromethorphan HBr 10 mg.............................Cough suppressant

Doxylamine succinate 6.25 mg.....................................Antihistamine

Phenylephrine HCl 5 mg......................................Nasal decongestant

Uses

■ temporarily relieves common cold/flu symptoms:

■ nasal congestion ■ sinus congestion & pressure

■ cough due to minor throat & bronchial irritation

■ cough to help you sleep ■ minor aches & pains ■ headache

■ fever ■ sore throat ■ runny nose & sneezing

■ reduces swelling of nasal passages

■ temporarily restores freer breathing through the nose

■ promotes nasal and/or sinus drainage

Warnings

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.

NIGHTTIME SEVERE COLD & FLU SOFTGELS

Drug Facts (continued)

Do not use

Ask a doctor before use if you have

■ liver disease ■ heart disease ■ high blood pressure

■ thyroid disease ■ diabetes ■ 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, and tranquilizers may increase drowsiness

NIGHTTIME SEVERE COLD & FLU SOFTGELS

Drug Facts (continued)

Stop use and ask a doctor if

SPL UNCLASSIFIED SECTION

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

Keep out of reach of children.

Overdose warning

Directions

■ take only as directed - see Overdose warning

■ do not exceed 4 doses per 24 hours


adults & children 12 years & over	2 softgels with water every 4 hours
children 4 to under 12 years	ask a doctor
children under 4 years	do not use

Other information

store at room temperature

Inactive ingredients

D&C Yellow #10, FD&C Blue #1, gelatin,

glycerin, polyethylene glycol 400, povidone K30, propylene glycol,

purified water, shellac, sorbitol sorbitan, sodium hydroxide, titanium

dioxide

Questions or comments?

Call toll free: 1-888-333-9792

PRINCIPAL DISPLAY PANEL

DAY & NIGHT PACK

Compare to Vicks® DayQuil® Severe

Cold & Flu & Vicks® NyQuil® Severe

Cold & Flu active ingredients*

DAYTIME • NON-DROWSY

Severe

Cold & Flu

ACETAMINOPHEN /

PAIN RELIEVER / FEVER REDUCER

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

GUAIFENESIN / EXPECTORANT

PHENYLEPHRINE HCl / NASAL DECONGESTANT

MAXIMUM STRENGTH

ACTUAL SIZE

16SOFTGELS

NIGHTTIME

Severe

Cold & Flu

ACETAMINOPHEN /

PAIN RELIEVER / FEVER REDUCER

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT

DOXYLAMINE SUCCINATE / ANTIHISTAMINE

PHENYLEPHRINE HCl / NASAL DECONGESTANT

MAXIMUM STRENGTH

ACTUAL SIZE

8SOFTGELS

24 SOFTGELS

INGREDIENTS AND APPEARANCE

SEVERE COLD AND FLU DAYTIME NON DROWSY NIGHTTIME

acetaminophen, dextromethorphan hydrobromide,guaifenesin, phenylephrine hydrochloride / acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-667

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-667-24	1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product	10/31/2019

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	2 BLISTER PACK	16
Part 2	1 BLISTER PACK	8

Part 1 of 2
SEVERE COLD AND FLU DAYTIME NON-DROWSY acetaminophen, dextromethorphan hydrobromide,guaifenesin, phenylephrine hydrochloride capsule, liquid filled

Product Information
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL (OBLONG)	Size	20mm
Flavor		Imprint Code	341
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	10/31/2019

Part 2 of 2
SEVERE COLD AND FLU NIGHTTIME acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled

Product Information
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Ingredient Name	Strength
Inactive Ingredients
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SHELLAC (UNII: 46N107B71O)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	green	Score	no score
Shape	OVAL (OBLONG)	Size	20mm
Flavor		Imprint Code	116
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	10/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	10/31/2019

Labeler - TopCo Associates LLC (006935977)

Revised: 11/2022

Document Id: ee2806c0-83dd-02c5-e053-2a95a90a742f

Set id: 74c9dd48-4440-4860-9d82-79701d881299

Version: 5

Effective Time: 20221123

Search by Drug Name or NDC

NDC 36800-0667-24 SEVERE COLD AND FLU Details

SEVERE COLD AND FLU

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 36800-0667-24 (36800066724)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 74c9dd48-4440-4860-9d82-79701d881299 Details

Daytime and Nighttime SEVERE COLD AND FLU

SPL UNCLASSIFIED SECTION

Uses

Warnings

Do not use

Ask a doctor before use if you have

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if

SPL UNCLASSIFIED SECTION

Overdose warning

Directions

Other information

Inactive ingredients

SPL UNCLASSIFIED SECTION

Uses

Warnings

NIGHTTIME SEVERE COLD & FLU SOFTGELS

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

NIGHTTIME SEVERE COLD & FLU SOFTGELS

Stop use and ask a doctor if

SPL UNCLASSIFIED SECTION

Overdose warning

Directions

Other information

Inactive ingredients

Questions or comments?

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE