CORICIDIN HBP MAXIMUM STRENGTH COLD AND FLU DAY AND NIGHT- acetaminophen, dextromethorphan hydrobromide, guaifenesin, doxylamine succinate kit

Coricidin HBP Maximum Strength Cold and Flu Day and Night by

Drug Labeling and Warnings

Coricidin HBP Maximum Strength Cold and Flu Day and Night by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Coricidin HBP® Maximum Strength Cold & Flu Day Liquid Gels

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Active ingredients (in each capsule) Purposes

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

Dextromethorphan hydrobromide 10 mg…………..Cough suppressant

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

Purpose

Uses

Uses

· temporarily relieves these symptoms due to a cold or flu:

· minor aches and pains · headache · cough

· sore throat

· helps loosen phlegm (mucus) and thin bronchial secretions to rid

the bronchial passageways of bothersome mucus and make

cough more productive

· temporarily reduces fever

Warnings

Warnings

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

· more than 4,000 mg of acetaminophen in 24 hours

· with other drugs containing acetaminophen

· 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin or severe

allergic reactions. Symptoms may include:

· skin reddening · blisters · rash · hives

· facial swelling · asthma (wheezing) · shock

If a skin or general allergic 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

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.

● if you have ever had an allergic reaction to this product or any of its

ingredients

● in children under 12 years of age

Aska a doctor

Ask a doctor before use if you have

● liver disease

● persistent or chronic cough such as occurs with smoking, asthma,

or emphysema

● cough with excessive phlegm (mucus)

Ask a doctor or pharmacist

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

Stop use

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. 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

Directions

· do not take more than the recommended dose

· do not take the Day and Night products at the same time; wait 4

hours after taking the last Night dose before taking the Day product.

· adults and children 12 years and over: take 2 capsules with water

every 4 hours. Do not exceed 6 capsules in 12 hours or as

directed by a doctor.

· children under 12 years of age: do not use

Other information

Other information

· store at 15º-25ºC (59º-77ºF)

Inactive ingrediens

Inactive ingredients FD&C red No.40, gelatin, glycerin, iron oxide black, lecithin, medium-chain triglycerides, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

Questions or comments? 1-800-317-2165 (Mon-Fri 9AM -5PM EST)

SPL UNCLASSIFIED SECTION

Coricidin® HBP Maximum Strength Cold & Flu Night Liquid Gels

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Active ingredients (in each capsule)Purposes

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

Dextromethorphan hydrobromide 10 mg……………Cough suppressant

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

PURPOSE

Uses

Uses

· temporarily relieves these symptoms due to a cold or flu:

· minor aches and pains · headache · cough

· sore throat · runny nose · sneezing

· temporarily reduces fever

Warnings

Warnings

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

· more than 4,000 mg of acetaminophen in 24 hours

· with other drugs containing acetaminophen

· 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin or severe

allergic reactions. Symptoms may include:

· skin reddening · blisters · rash · hives

· facial swelling · asthma (wheezing) · shock

If a skin or general allergic 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 to sedate children

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.

● if you have ever had an allergic reaction to this product or any of its

ingredients

● in children under 12 years of age

Ask a doctor before use if you have

Ask a doctor before use if you have

● liver disease ● glaucoma

● persistent or chronic cough such as occurs with smoking, asthma,

or emphysema

● cough with excessive phlegm (mucus)

● a breathing problem such as emphysema or chronic bronchitis

● difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

Ask a doctor or pharmacist before use if you are

● taking the blood thinning drug warfarin

● taking sedatives or tranquilizers

When using this product

When using this product

● may cause marked drowsiness

● avoid alcoholic beverages

● alcohol, sedatives, and tranquilizers may increase drowsiness

● be careful when driving a motor vehicle or operating machinery

● excitability may occur, especially in children

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. 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

Directions

· do not take more than the recommended dose

· do not take the Day and Night products at the same time; wait 4

hours after taking the last Day dose before taking the Night product.

· adults and children 12 years and over: take 2 capsules with water

every 4 hours. Do not exceed 4 capsules in 12 hours or as

directed by a doctor.

· children under 12 years of age: do not use

Other information

Other information

· store at 15º-25ºC (59º-77ºF)

Questions or Comments

Questions or comments?1-800-317-2165 (Mon-Fri 9AM -5PM EST)

PRINCIPAL DISPLAY PANEL

Coricidin® HBP

COLD RELIEF FOR PEOPLE WITH HIGH BLOOD PRESSUREƗ

MAXIMUM STRENGTH

COLD & FLU DAY

GUAIFENESIN - Expectorant

DEXTROMETHORPHAN HBr - Cough Supressant

ACETAMINOPHEN - Pain Reliever/Fever Reducer

Relieves

• Body Aches & Pains
• Headache
• Chest Congestant
• Cough
• Sore Throat
• Fever

Ɨ Decongestant Free

16 LIQUID GELS

(Liquid Filled Capsules)

COLD & FLU NIGHT

DOXYLAMINE SUCCINATE - Antihistamine

DEXTROMETHORPHAN HBr - Cough Suppresant

ACETAMINOPHEN - Pain Reliever/Fever Reducer

RELIEVES

• Body Aches & Pains
• Headache
• Runny Nose & Sneezing
• Cough
• Sore Throat
• Fever

Ɨ Decongestant Free

8 LIQUID GELS

(Liquid Filled Capsules)

INGREDIENTS AND APPEARANCE

CORICIDIN HBP MAXIMUM STRENGTH COLD AND FLU DAY AND NIGHT 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-0026

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-0026-1	1 in 1 BLISTER PACK; Type 0: Not a Combination Product	07/01/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	4 BLISTER PACK	8
Part 2	2 BLISTER PACK	4

Part 1 of 2

CORICIDIN HBP MAXIMUM STRENGTH COLD AND FLU DAY 
acetaminophen, dextromethorphan hydrobromide, guaifenesin capsule, liquid filled

Product Information
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SHELLAC (UNII: 46N107B71O)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITAN (UNII: 6O92ICV9RU)
IRON (UNII: E1UOL152H7)
POTASSIUM ALUMINUM DISILICATE (UNII: SRB14JRX6C)
POVIDONE (UNII: FZ989GH94E)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
GELATIN (UNII: 2G86QN327L)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	CHBPD
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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	07/01/2020

Part 2 of 2

CORICIDIN HBP MAXIMUM STRENGTH COLD AND FLU NIGHT 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled

Product Information
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM ALUMINUM DISILICATE (UNII: SRB14JRX6C)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SHELLAC (UNII: 46N107B71O)
SORBITAN (UNII: 6O92ICV9RU)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POVIDONE (UNII: FZ989GH94E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITOL (UNII: 506T60A25R)
SOYBEAN OIL (UNII: 241ATL177A)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	CHBPN
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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	07/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/01/2020

Labeler - Bayer HealthCare LLC. (112117283)